Neonatal Medicine

The U.S. Food and Drug Administration is easing rules to allow infant formula imports from the United Kingdom, which would bring about 2 million cans to the U.S. in coming weeks.

Kendal Nutricare will be able to offer certain infant formula products under the Kendamil brand to ease the nationwide formula shortage.

“Importantly, we anticipate additional infant formula products may be safely and quickly imported in the U.S. in the near-term, based on ongoing discussions with manufacturers and suppliers worldwide,” Robert Califf, MD, the FDA commissioner, said in a statement.

Kendal Nutricare has more than 40,000 cans in stock for immediate dispatch, the FDA said, and the U.S. Department of Health and Human Services is talking to the company about the best ways to get the products to the U.S. as quickly as possible.

Kendamil has set up a website for consumers to receive updates and find products once they arrive in the U.S.

After an evaluation, the FDA said it had no safety or nutrition concerns about the products. The evaluation reviewed the company’s microbiological testing, labeling, and information about facility production and inspection history.

On May 24, the FDA announced that Abbott Nutrition will release about 300,000 cans of its EleCare specialty amino acid-based formula to families that need urgent, life-sustaining supplies. The products had more tests for microbes before release.

Although some EleCare products were included in Abbott’s infant formula recall earlier this year, the cans that will be released were in different lots, have never been released, and have been maintained in storage, the FDA said.

“These EleCare product lots were not part of the recall but have been on hold due to concerns that they were produced under unsanitary conditions observed at Abbott Nutrition’s Sturgis, Michigan, facility,” the FDA wrote.

The FDA encourages parents and caregivers to talk with their health care providers to weigh the potential risk of bacterial infection with the critical need for the product, based on its special dietary formulation for infants with severe food allergies or gut disorders.

The FDA also said that Abbott confirmed the EleCare products will be the first formula produced at the Sturgis facility when it restarts production soon. Other specialty metabolic formulas will follow.

Abbott plans to restart production at the Sturgis facility on June 4, the company said in a statement, noting that the early batches of EleCare would be available to consumers around June 20.

The products being released now are EleCare (for infants under 1 year) and EleCare Jr. (for ages 1 and older). Those who want to request products should contact their health care providers or call Abbott directly at 800-881-0876.

A version of this article first appeared on WebMD.com.

The U.S. Food and Drug Administration is easing rules to allow infant formula imports from the United Kingdom, which would bring about 2 million cans to the U.S. in coming weeks.

Kendal Nutricare will be able to offer certain infant formula products under the Kendamil brand to ease the nationwide formula shortage.

“Importantly, we anticipate additional infant formula products may be safely and quickly imported in the U.S. in the near-term, based on ongoing discussions with manufacturers and suppliers worldwide,” Robert Califf, MD, the FDA commissioner, said in a statement.

Kendal Nutricare has more than 40,000 cans in stock for immediate dispatch, the FDA said, and the U.S. Department of Health and Human Services is talking to the company about the best ways to get the products to the U.S. as quickly as possible.

Kendamil has set up a website for consumers to receive updates and find products once they arrive in the U.S.

After an evaluation, the FDA said it had no safety or nutrition concerns about the products. The evaluation reviewed the company’s microbiological testing, labeling, and information about facility production and inspection history.

On May 24, the FDA announced that Abbott Nutrition will release about 300,000 cans of its EleCare specialty amino acid-based formula to families that need urgent, life-sustaining supplies. The products had more tests for microbes before release.

Although some EleCare products were included in Abbott’s infant formula recall earlier this year, the cans that will be released were in different lots, have never been released, and have been maintained in storage, the FDA said.

“These EleCare product lots were not part of the recall but have been on hold due to concerns that they were produced under unsanitary conditions observed at Abbott Nutrition’s Sturgis, Michigan, facility,” the FDA wrote.

The FDA encourages parents and caregivers to talk with their health care providers to weigh the potential risk of bacterial infection with the critical need for the product, based on its special dietary formulation for infants with severe food allergies or gut disorders.

The FDA also said that Abbott confirmed the EleCare products will be the first formula produced at the Sturgis facility when it restarts production soon. Other specialty metabolic formulas will follow.

Abbott plans to restart production at the Sturgis facility on June 4, the company said in a statement, noting that the early batches of EleCare would be available to consumers around June 20.

The products being released now are EleCare (for infants under 1 year) and EleCare Jr. (for ages 1 and older). Those who want to request products should contact their health care providers or call Abbott directly at 800-881-0876.

A version of this article first appeared on WebMD.com.

The U.S. Food and Drug Administration is easing rules to allow infant formula imports from the United Kingdom, which would bring about 2 million cans to the U.S. in coming weeks.

Kendal Nutricare will be able to offer certain infant formula products under the Kendamil brand to ease the nationwide formula shortage.

“Importantly, we anticipate additional infant formula products may be safely and quickly imported in the U.S. in the near-term, based on ongoing discussions with manufacturers and suppliers worldwide,” Robert Califf, MD, the FDA commissioner, said in a statement.

Kendal Nutricare has more than 40,000 cans in stock for immediate dispatch, the FDA said, and the U.S. Department of Health and Human Services is talking to the company about the best ways to get the products to the U.S. as quickly as possible.

Kendamil has set up a website for consumers to receive updates and find products once they arrive in the U.S.

After an evaluation, the FDA said it had no safety or nutrition concerns about the products. The evaluation reviewed the company’s microbiological testing, labeling, and information about facility production and inspection history.

On May 24, the FDA announced that Abbott Nutrition will release about 300,000 cans of its EleCare specialty amino acid-based formula to families that need urgent, life-sustaining supplies. The products had more tests for microbes before release.

Although some EleCare products were included in Abbott’s infant formula recall earlier this year, the cans that will be released were in different lots, have never been released, and have been maintained in storage, the FDA said.

“These EleCare product lots were not part of the recall but have been on hold due to concerns that they were produced under unsanitary conditions observed at Abbott Nutrition’s Sturgis, Michigan, facility,” the FDA wrote.

The FDA encourages parents and caregivers to talk with their health care providers to weigh the potential risk of bacterial infection with the critical need for the product, based on its special dietary formulation for infants with severe food allergies or gut disorders.

The FDA also said that Abbott confirmed the EleCare products will be the first formula produced at the Sturgis facility when it restarts production soon. Other specialty metabolic formulas will follow.

Abbott plans to restart production at the Sturgis facility on June 4, the company said in a statement, noting that the early batches of EleCare would be available to consumers around June 20.

The products being released now are EleCare (for infants under 1 year) and EleCare Jr. (for ages 1 and older). Those who want to request products should contact their health care providers or call Abbott directly at 800-881-0876.

A version of this article first appeared on WebMD.com.

Meghan Block of Weymouth, Mass., starts her search at 5 a.m. every morning – combing local retailer websites for baby formula.

Her own children have been off it for years. But her cousin in New Hampshire has a 2-month-old son who needs hypoallergenic formula, and the nationwide shortage has left the new mom scrambling to find what her baby needs.

“I’d equate this to how we were all frantically looking for vaccine appointments when they first rolled out,” Ms. Block said. “Parents are all mobilizing for each other.”

She added, “What people aren’t talking about is the stress on new mothers this is causing. If you’re on the edge of the baby blues and postpartum depression, and you can’t find food for your babies – these parents could be in crisis.”

For weeks, a pandemic-induced supply chain shortage – along with a massive recall from top formula manufacturer Abbott Nutrition – has left shelves empty and parents panicked, fearing their dwindling formula supplies will disappear entirely.

Abbott announced that its previously shuttered Michigan factory would reopen, but it remains unclear how soon that will make a noticeable difference.

The Food and Drug Administration announced Monday, May 16, that it would ease restrictions for selling foreign-made baby formula in the U.S. to broaden supply.

President Joe Biden invoked the the Defense Production Act on May 18, which requires suppliers to send resources to formula plants before giving them to other customers. The president is also authorizing the Defense Department to use commercial aircraft to pick up infant formula overseas that meets federal standards and fly it to the U.S. – a measure dubbed “Operation Fly Formula.”

But in the meantime, hospital staff and pediatricians are fielding questions from parents that they can’t always answer.

“People want to know if the shortage is ending soon, and that’s hard to predict. Even with the factory back online, the end could still be 1-3 months away,” Joshua Wechsler, MD, pediatric gastroenterologist at Ann & Robert H. Lurie Children’s Hospital of Chicago, said in an interview.

Most formulas on the market have comparable alternatives, Dr. Wechsler said, but there are fewer options for parents of special-needs babies – those with allergies and specific dietary requirements.

This has required around-the-clock work from dietitians and pediatricians to find sufficient options for these babies and monitor their ability to tolerate new kinds of formula.

“We’re advising parents not to dilute formula, not to buy it from sources you’re unfamiliar with, and no homemade formulas,” Dr. Wechsler said.

He said in some instances he has seen weight loss among babies whose supplies were stretching thin, and in very rare cases, hospitalizations.

According to recent reports, two children were hospitalized in mid-May at Le Bonheur Children’s Hospital, Memphis, Tenn., as a result of the formula shortage.

Those most affected by the crisis, doctors say, are lower-income families. Half of the infant formula purchased in the United States is through Women, Infants, and Children (WIC) benefits, a federal assistance program, which provides formula for free but only limited types and brands.

But in most cases, hospitals and pediatricians have the means to provide caregivers with supplementary formula, said Amy Hair, MD, program director of neonatal nutrition at Texas Children’s Hospital.

“Here in the hospital, we’re OK, because we’re able to switch through different options for patients and we’re sending families home with a short supply to bridge them over,” Dr. Hair said. “We encourage patients to talk to their pediatricians, who usually have in-office supplies.”

She also advises parents to look in smaller pharmacies and stores rather than bigger retailers, along with ordering it straight from the formula manufacturers online.

“We’re reassuring families we think this is temporary,” Dr. Hair said. “Providers have been dealing with this for a while, so we have some strategies in place to help caregivers through the shortage.”

In the meantime, parents continue to lean on each other for help and resources. Ms. Block’s cousin in New Hampshire, Jamie Boudreau, said she has friends and family on the lookout across the country for hypoallergenic formula for her son.

She currently has about a 1-month supply, but she worries constantly that will be depleted before the shortage ends.

“It’s definitely been very stressful,” Ms. Boudreau said. “I, as an adult, can go days without eating, but my tiny 2-month-old little boy – he can’t go more than 3 hours. What am I going to do if in 4 weeks I don’t have any more?”

Meghan Block of Weymouth, Mass., starts her search at 5 a.m. every morning – combing local retailer websites for baby formula.

Her own children have been off it for years. But her cousin in New Hampshire has a 2-month-old son who needs hypoallergenic formula, and the nationwide shortage has left the new mom scrambling to find what her baby needs.

“I’d equate this to how we were all frantically looking for vaccine appointments when they first rolled out,” Ms. Block said. “Parents are all mobilizing for each other.”

She added, “What people aren’t talking about is the stress on new mothers this is causing. If you’re on the edge of the baby blues and postpartum depression, and you can’t find food for your babies – these parents could be in crisis.”

For weeks, a pandemic-induced supply chain shortage – along with a massive recall from top formula manufacturer Abbott Nutrition – has left shelves empty and parents panicked, fearing their dwindling formula supplies will disappear entirely.

Abbott announced that its previously shuttered Michigan factory would reopen, but it remains unclear how soon that will make a noticeable difference.

The Food and Drug Administration announced Monday, May 16, that it would ease restrictions for selling foreign-made baby formula in the U.S. to broaden supply.

President Joe Biden invoked the the Defense Production Act on May 18, which requires suppliers to send resources to formula plants before giving them to other customers. The president is also authorizing the Defense Department to use commercial aircraft to pick up infant formula overseas that meets federal standards and fly it to the U.S. – a measure dubbed “Operation Fly Formula.”

But in the meantime, hospital staff and pediatricians are fielding questions from parents that they can’t always answer.

“People want to know if the shortage is ending soon, and that’s hard to predict. Even with the factory back online, the end could still be 1-3 months away,” Joshua Wechsler, MD, pediatric gastroenterologist at Ann & Robert H. Lurie Children’s Hospital of Chicago, said in an interview.

Most formulas on the market have comparable alternatives, Dr. Wechsler said, but there are fewer options for parents of special-needs babies – those with allergies and specific dietary requirements.

This has required around-the-clock work from dietitians and pediatricians to find sufficient options for these babies and monitor their ability to tolerate new kinds of formula.

“We’re advising parents not to dilute formula, not to buy it from sources you’re unfamiliar with, and no homemade formulas,” Dr. Wechsler said.

He said in some instances he has seen weight loss among babies whose supplies were stretching thin, and in very rare cases, hospitalizations.

According to recent reports, two children were hospitalized in mid-May at Le Bonheur Children’s Hospital, Memphis, Tenn., as a result of the formula shortage.

Those most affected by the crisis, doctors say, are lower-income families. Half of the infant formula purchased in the United States is through Women, Infants, and Children (WIC) benefits, a federal assistance program, which provides formula for free but only limited types and brands.

But in most cases, hospitals and pediatricians have the means to provide caregivers with supplementary formula, said Amy Hair, MD, program director of neonatal nutrition at Texas Children’s Hospital.

“Here in the hospital, we’re OK, because we’re able to switch through different options for patients and we’re sending families home with a short supply to bridge them over,” Dr. Hair said. “We encourage patients to talk to their pediatricians, who usually have in-office supplies.”

She also advises parents to look in smaller pharmacies and stores rather than bigger retailers, along with ordering it straight from the formula manufacturers online.

“We’re reassuring families we think this is temporary,” Dr. Hair said. “Providers have been dealing with this for a while, so we have some strategies in place to help caregivers through the shortage.”

In the meantime, parents continue to lean on each other for help and resources. Ms. Block’s cousin in New Hampshire, Jamie Boudreau, said she has friends and family on the lookout across the country for hypoallergenic formula for her son.

She currently has about a 1-month supply, but she worries constantly that will be depleted before the shortage ends.

“It’s definitely been very stressful,” Ms. Boudreau said. “I, as an adult, can go days without eating, but my tiny 2-month-old little boy – he can’t go more than 3 hours. What am I going to do if in 4 weeks I don’t have any more?”

Meghan Block of Weymouth, Mass., starts her search at 5 a.m. every morning – combing local retailer websites for baby formula.

Her own children have been off it for years. But her cousin in New Hampshire has a 2-month-old son who needs hypoallergenic formula, and the nationwide shortage has left the new mom scrambling to find what her baby needs.

“I’d equate this to how we were all frantically looking for vaccine appointments when they first rolled out,” Ms. Block said. “Parents are all mobilizing for each other.”

She added, “What people aren’t talking about is the stress on new mothers this is causing. If you’re on the edge of the baby blues and postpartum depression, and you can’t find food for your babies – these parents could be in crisis.”

For weeks, a pandemic-induced supply chain shortage – along with a massive recall from top formula manufacturer Abbott Nutrition – has left shelves empty and parents panicked, fearing their dwindling formula supplies will disappear entirely.

Abbott announced that its previously shuttered Michigan factory would reopen, but it remains unclear how soon that will make a noticeable difference.

The Food and Drug Administration announced Monday, May 16, that it would ease restrictions for selling foreign-made baby formula in the U.S. to broaden supply.

President Joe Biden invoked the the Defense Production Act on May 18, which requires suppliers to send resources to formula plants before giving them to other customers. The president is also authorizing the Defense Department to use commercial aircraft to pick up infant formula overseas that meets federal standards and fly it to the U.S. – a measure dubbed “Operation Fly Formula.”

But in the meantime, hospital staff and pediatricians are fielding questions from parents that they can’t always answer.

“People want to know if the shortage is ending soon, and that’s hard to predict. Even with the factory back online, the end could still be 1-3 months away,” Joshua Wechsler, MD, pediatric gastroenterologist at Ann & Robert H. Lurie Children’s Hospital of Chicago, said in an interview.

Most formulas on the market have comparable alternatives, Dr. Wechsler said, but there are fewer options for parents of special-needs babies – those with allergies and specific dietary requirements.

This has required around-the-clock work from dietitians and pediatricians to find sufficient options for these babies and monitor their ability to tolerate new kinds of formula.

“We’re advising parents not to dilute formula, not to buy it from sources you’re unfamiliar with, and no homemade formulas,” Dr. Wechsler said.

He said in some instances he has seen weight loss among babies whose supplies were stretching thin, and in very rare cases, hospitalizations.

According to recent reports, two children were hospitalized in mid-May at Le Bonheur Children’s Hospital, Memphis, Tenn., as a result of the formula shortage.

Those most affected by the crisis, doctors say, are lower-income families. Half of the infant formula purchased in the United States is through Women, Infants, and Children (WIC) benefits, a federal assistance program, which provides formula for free but only limited types and brands.

But in most cases, hospitals and pediatricians have the means to provide caregivers with supplementary formula, said Amy Hair, MD, program director of neonatal nutrition at Texas Children’s Hospital.

“Here in the hospital, we’re OK, because we’re able to switch through different options for patients and we’re sending families home with a short supply to bridge them over,” Dr. Hair said. “We encourage patients to talk to their pediatricians, who usually have in-office supplies.”

She also advises parents to look in smaller pharmacies and stores rather than bigger retailers, along with ordering it straight from the formula manufacturers online.

“We’re reassuring families we think this is temporary,” Dr. Hair said. “Providers have been dealing with this for a while, so we have some strategies in place to help caregivers through the shortage.”

In the meantime, parents continue to lean on each other for help and resources. Ms. Block’s cousin in New Hampshire, Jamie Boudreau, said she has friends and family on the lookout across the country for hypoallergenic formula for her son.

She currently has about a 1-month supply, but she worries constantly that will be depleted before the shortage ends.

“It’s definitely been very stressful,” Ms. Boudreau said. “I, as an adult, can go days without eating, but my tiny 2-month-old little boy – he can’t go more than 3 hours. What am I going to do if in 4 weeks I don’t have any more?”

Reduced levels of the cholinergic-system enzyme butyrylcholinesterase (BChE) may provide another piece of the puzzle for sudden infant death syndrome (SIDS), preliminary data from Australian researchers suggested.

A small case-control study led by Carmel T. Harrington, PhD,* a sleep medicine expert and honorary research fellow at the Children’s Hospital at Westmead (Australia), found that measurements in 722 dried blood spots taken during neonatal screening 2 or 3 days after birth were lower in babies who subsequently died of SIDS, compared with those of matched surviving controls and other babies who died of non-SIDS causes.

* This story was corrected on 5/20/2022.

Reduced levels of the cholinergic-system enzyme butyrylcholinesterase (BChE) may provide another piece of the puzzle for sudden infant death syndrome (SIDS), preliminary data from Australian researchers suggested.

A small case-control study led by Carmel T. Harrington, PhD,* a sleep medicine expert and honorary research fellow at the Children’s Hospital at Westmead (Australia), found that measurements in 722 dried blood spots taken during neonatal screening 2 or 3 days after birth were lower in babies who subsequently died of SIDS, compared with those of matched surviving controls and other babies who died of non-SIDS causes.

* This story was corrected on 5/20/2022.

Reduced levels of the cholinergic-system enzyme butyrylcholinesterase (BChE) may provide another piece of the puzzle for sudden infant death syndrome (SIDS), preliminary data from Australian researchers suggested.

A small case-control study led by Carmel T. Harrington, PhD,* a sleep medicine expert and honorary research fellow at the Children’s Hospital at Westmead (Australia), found that measurements in 722 dried blood spots taken during neonatal screening 2 or 3 days after birth were lower in babies who subsequently died of SIDS, compared with those of matched surviving controls and other babies who died of non-SIDS causes.

* This story was corrected on 5/20/2022.

The Food and Drug Administration announced on May 10 that it is taking several steps to improve the supply of baby formula in the United States.

The nationwide formula shortage has grown worse in recent weeks due to supply chain issues and a recall of certain Abbott Nutrition products, including major labels such as Similac, Alimentum, and EleCare.

“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so,” FDA Commissioner Robert Califf, MD, said in a statement.

“We are doing everything in our power to ensure there is adequate product available where and when they need it,” he said.

About three-quarters of babies are fed formula for the first 6 months of their lives as a substitute for human milk, Axios reported.

In mid-February, the FDA warned consumers not to use certain powdered infant formula products from Abbott’s facility in Sturgis, Mich. Since then, the FDA has been working with Abbott and other manufacturers to increase the supply in the U.S. market.

“In fact, other infant formula manufacturers are meeting or exceeding capacity levels to meet current demand,” the FDA said in the statement. “Notably, more infant formula was purchased in the month of April than in the month prior to the recall.”

The FDA released a list of steps the agency is taking to increase supply, such as meeting with major infant formula makers to increase output and prioritize product lines in high demand, particularly specialty formulas for infants with allergies or specific diet needs.

But other manufacturers have struggled to quickly increase production because their operations tend to focus on a steady level of supply, according to The New York Times.

“Some industries are very good at ramping up and ramping down,” Rudi Leuschner, PhD, an associate professor of supply chain management at Rutgers Business School, Newark, N.J., told the newspaper.

“You flip a switch and they can produce 10 times as much,” he said. “Baby formula is not that type of a product.”

The FDA is also keeping an eye on the infant formula shortage by using the agency’s 21 Forward food supply chain continuity system. The system was developed during the pandemic to provide a full understanding of how COVID-19 is impacting food supply chains, the FDA said.

The FDA is compiling data on trends for in-stock rates at national and regional levels to understand where infant formula is available and where it should go.

Products are also being brought in from other countries, the FDA said. The agency is trying to speed up the process to get more formula into the U.S. and move it more quickly around the country.

For babies on a special diet, the FDA has decided to release some Abbott products that have been on hold at the Sturgis facility to those who need an urgent supply of metabolic formulas, on a case-by-case basis.

“In these circumstances, the benefit of allowing caregivers, in consultation with their health care providers, to access these products may outweigh the potential risk of bacterial infection,” the FDA said in the statement.

The FDA continues to advise against making homemade infant formulas and recommends talking to the child’s health care provider for recommendations on changing feeding practices or switching to other formulas, if necessary.

A version of this article first appeared on WebMd.com.

The Food and Drug Administration announced on May 10 that it is taking several steps to improve the supply of baby formula in the United States.

The nationwide formula shortage has grown worse in recent weeks due to supply chain issues and a recall of certain Abbott Nutrition products, including major labels such as Similac, Alimentum, and EleCare.

“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so,” FDA Commissioner Robert Califf, MD, said in a statement.

“We are doing everything in our power to ensure there is adequate product available where and when they need it,” he said.

About three-quarters of babies are fed formula for the first 6 months of their lives as a substitute for human milk, Axios reported.

In mid-February, the FDA warned consumers not to use certain powdered infant formula products from Abbott’s facility in Sturgis, Mich. Since then, the FDA has been working with Abbott and other manufacturers to increase the supply in the U.S. market.

“In fact, other infant formula manufacturers are meeting or exceeding capacity levels to meet current demand,” the FDA said in the statement. “Notably, more infant formula was purchased in the month of April than in the month prior to the recall.”

The FDA released a list of steps the agency is taking to increase supply, such as meeting with major infant formula makers to increase output and prioritize product lines in high demand, particularly specialty formulas for infants with allergies or specific diet needs.

But other manufacturers have struggled to quickly increase production because their operations tend to focus on a steady level of supply, according to The New York Times.

“Some industries are very good at ramping up and ramping down,” Rudi Leuschner, PhD, an associate professor of supply chain management at Rutgers Business School, Newark, N.J., told the newspaper.

“You flip a switch and they can produce 10 times as much,” he said. “Baby formula is not that type of a product.”

The FDA is also keeping an eye on the infant formula shortage by using the agency’s 21 Forward food supply chain continuity system. The system was developed during the pandemic to provide a full understanding of how COVID-19 is impacting food supply chains, the FDA said.

The FDA is compiling data on trends for in-stock rates at national and regional levels to understand where infant formula is available and where it should go.

Products are also being brought in from other countries, the FDA said. The agency is trying to speed up the process to get more formula into the U.S. and move it more quickly around the country.

For babies on a special diet, the FDA has decided to release some Abbott products that have been on hold at the Sturgis facility to those who need an urgent supply of metabolic formulas, on a case-by-case basis.

“In these circumstances, the benefit of allowing caregivers, in consultation with their health care providers, to access these products may outweigh the potential risk of bacterial infection,” the FDA said in the statement.

The FDA continues to advise against making homemade infant formulas and recommends talking to the child’s health care provider for recommendations on changing feeding practices or switching to other formulas, if necessary.

A version of this article first appeared on WebMd.com.

The Food and Drug Administration announced on May 10 that it is taking several steps to improve the supply of baby formula in the United States.

The nationwide formula shortage has grown worse in recent weeks due to supply chain issues and a recall of certain Abbott Nutrition products, including major labels such as Similac, Alimentum, and EleCare.

“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so,” FDA Commissioner Robert Califf, MD, said in a statement.

“We are doing everything in our power to ensure there is adequate product available where and when they need it,” he said.

About three-quarters of babies are fed formula for the first 6 months of their lives as a substitute for human milk, Axios reported.

In mid-February, the FDA warned consumers not to use certain powdered infant formula products from Abbott’s facility in Sturgis, Mich. Since then, the FDA has been working with Abbott and other manufacturers to increase the supply in the U.S. market.

“In fact, other infant formula manufacturers are meeting or exceeding capacity levels to meet current demand,” the FDA said in the statement. “Notably, more infant formula was purchased in the month of April than in the month prior to the recall.”

The FDA released a list of steps the agency is taking to increase supply, such as meeting with major infant formula makers to increase output and prioritize product lines in high demand, particularly specialty formulas for infants with allergies or specific diet needs.

But other manufacturers have struggled to quickly increase production because their operations tend to focus on a steady level of supply, according to The New York Times.

“Some industries are very good at ramping up and ramping down,” Rudi Leuschner, PhD, an associate professor of supply chain management at Rutgers Business School, Newark, N.J., told the newspaper.

“You flip a switch and they can produce 10 times as much,” he said. “Baby formula is not that type of a product.”

The FDA is also keeping an eye on the infant formula shortage by using the agency’s 21 Forward food supply chain continuity system. The system was developed during the pandemic to provide a full understanding of how COVID-19 is impacting food supply chains, the FDA said.

The FDA is compiling data on trends for in-stock rates at national and regional levels to understand where infant formula is available and where it should go.

Products are also being brought in from other countries, the FDA said. The agency is trying to speed up the process to get more formula into the U.S. and move it more quickly around the country.

For babies on a special diet, the FDA has decided to release some Abbott products that have been on hold at the Sturgis facility to those who need an urgent supply of metabolic formulas, on a case-by-case basis.

“In these circumstances, the benefit of allowing caregivers, in consultation with their health care providers, to access these products may outweigh the potential risk of bacterial infection,” the FDA said in the statement.

The FDA continues to advise against making homemade infant formulas and recommends talking to the child’s health care provider for recommendations on changing feeding practices or switching to other formulas, if necessary.

A version of this article first appeared on WebMd.com.

Recently, I encountered a study in Pediatrics that hoped to answer the question of whether there was any benefit to tactile stimulation in those nerve-rattling moments when a newborn didn’t seem to take much interest in breathing: “Tactile stimulation in newborn infants with inadequate respiration at birth: A systematic review.” Now there is a title that grabs the attention of every frontline pediatrician who has sweated through those minutes that seemed like hours in the delivery room when some little rascal has decided that breathing isn’t a priority.

Of course, your great grandmother and everyone else knew what needed to be done – the obstetrician hung the baby by his or her ankles and slapped it on the bottom a couple of times. But you went to medical school and learned that was barbaric. Instead, you modeled the behavior of the residents and delivery room nurses who had more refined techniques such as heel flicking and vigorous spine rubbing. You never thought to ask if there was any science behind those activities because everyone did them.

Well, the authors of the article in Pediatrics, writing on behalf of the International Liaison Committee on Resuscitation and Neonatal Life Support Task Force, thought the time had come to turn over a few stones and see if tactile stimulation was a benefit in resuscitation. Beginning with 2,455 possibly relevant articles, they quickly (I suspect they would quibble with the “quickly” part) winnowed these down to two observational studies, one of which was rejected because of “critical risk of bias.” The surviving study showed a reduction in tracheal intubation in infants who had received tactile stimulation. However, the authors felt that the “certainty of evidence was very low.”

So, there you have it. Aren’t you glad you didn’t invest 15 or 20 minutes discovering what you probably had guessed already? You can thank me later.

You already suspected that it may not help. However, like any good physician, what you really wanted to know is whether were you doing any harm by heel flicking and spine rubbing. And I bet you already had an opinion about the answer to that question. During your training, you may have seen delivery room personnel who were clearly too vigorous in their tactile stimulation and/or too persistent in their heel flicking and spine rubbing when the next steps in resuscitation needed to be taken. That’s the next study that needs to be done. I hope that study finds that tactile stimulation may not help but as long as it is done using specific techniques and within certain temporal parameters it does no harm.

I was never much for heel flicking. My favorite tactile stimulation was encircling the pokey infant’s chest in my hand, gently compressing and then quickly releasing a couple of times. My hope was that by mimicking the birth process the sensors in the infant’s chest wall would remind him it was time to breathe. That, and a silent plea to Mother Nature, worked most of the time.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

Recently, I encountered a study in Pediatrics that hoped to answer the question of whether there was any benefit to tactile stimulation in those nerve-rattling moments when a newborn didn’t seem to take much interest in breathing: “Tactile stimulation in newborn infants with inadequate respiration at birth: A systematic review.” Now there is a title that grabs the attention of every frontline pediatrician who has sweated through those minutes that seemed like hours in the delivery room when some little rascal has decided that breathing isn’t a priority.

Of course, your great grandmother and everyone else knew what needed to be done – the obstetrician hung the baby by his or her ankles and slapped it on the bottom a couple of times. But you went to medical school and learned that was barbaric. Instead, you modeled the behavior of the residents and delivery room nurses who had more refined techniques such as heel flicking and vigorous spine rubbing. You never thought to ask if there was any science behind those activities because everyone did them.

Well, the authors of the article in Pediatrics, writing on behalf of the International Liaison Committee on Resuscitation and Neonatal Life Support Task Force, thought the time had come to turn over a few stones and see if tactile stimulation was a benefit in resuscitation. Beginning with 2,455 possibly relevant articles, they quickly (I suspect they would quibble with the “quickly” part) winnowed these down to two observational studies, one of which was rejected because of “critical risk of bias.” The surviving study showed a reduction in tracheal intubation in infants who had received tactile stimulation. However, the authors felt that the “certainty of evidence was very low.”

So, there you have it. Aren’t you glad you didn’t invest 15 or 20 minutes discovering what you probably had guessed already? You can thank me later.

You already suspected that it may not help. However, like any good physician, what you really wanted to know is whether were you doing any harm by heel flicking and spine rubbing. And I bet you already had an opinion about the answer to that question. During your training, you may have seen delivery room personnel who were clearly too vigorous in their tactile stimulation and/or too persistent in their heel flicking and spine rubbing when the next steps in resuscitation needed to be taken. That’s the next study that needs to be done. I hope that study finds that tactile stimulation may not help but as long as it is done using specific techniques and within certain temporal parameters it does no harm.

I was never much for heel flicking. My favorite tactile stimulation was encircling the pokey infant’s chest in my hand, gently compressing and then quickly releasing a couple of times. My hope was that by mimicking the birth process the sensors in the infant’s chest wall would remind him it was time to breathe. That, and a silent plea to Mother Nature, worked most of the time.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

Recently, I encountered a study in Pediatrics that hoped to answer the question of whether there was any benefit to tactile stimulation in those nerve-rattling moments when a newborn didn’t seem to take much interest in breathing: “Tactile stimulation in newborn infants with inadequate respiration at birth: A systematic review.” Now there is a title that grabs the attention of every frontline pediatrician who has sweated through those minutes that seemed like hours in the delivery room when some little rascal has decided that breathing isn’t a priority.

Of course, your great grandmother and everyone else knew what needed to be done – the obstetrician hung the baby by his or her ankles and slapped it on the bottom a couple of times. But you went to medical school and learned that was barbaric. Instead, you modeled the behavior of the residents and delivery room nurses who had more refined techniques such as heel flicking and vigorous spine rubbing. You never thought to ask if there was any science behind those activities because everyone did them.

Well, the authors of the article in Pediatrics, writing on behalf of the International Liaison Committee on Resuscitation and Neonatal Life Support Task Force, thought the time had come to turn over a few stones and see if tactile stimulation was a benefit in resuscitation. Beginning with 2,455 possibly relevant articles, they quickly (I suspect they would quibble with the “quickly” part) winnowed these down to two observational studies, one of which was rejected because of “critical risk of bias.” The surviving study showed a reduction in tracheal intubation in infants who had received tactile stimulation. However, the authors felt that the “certainty of evidence was very low.”

So, there you have it. Aren’t you glad you didn’t invest 15 or 20 minutes discovering what you probably had guessed already? You can thank me later.

You already suspected that it may not help. However, like any good physician, what you really wanted to know is whether were you doing any harm by heel flicking and spine rubbing. And I bet you already had an opinion about the answer to that question. During your training, you may have seen delivery room personnel who were clearly too vigorous in their tactile stimulation and/or too persistent in their heel flicking and spine rubbing when the next steps in resuscitation needed to be taken. That’s the next study that needs to be done. I hope that study finds that tactile stimulation may not help but as long as it is done using specific techniques and within certain temporal parameters it does no harm.

I was never much for heel flicking. My favorite tactile stimulation was encircling the pokey infant’s chest in my hand, gently compressing and then quickly releasing a couple of times. My hope was that by mimicking the birth process the sensors in the infant’s chest wall would remind him it was time to breathe. That, and a silent plea to Mother Nature, worked most of the time.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

LISBON – A shift toward broader-spectrum antibiotics and increasing antibiotic resistance has led to high levels of mortality and neurodevelopmental impacts in surviving babies, according to a large international study conducted on four continents.

Results of the 3-year study were presented at this week’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).

The observational study, NeoOBS, conducted by the Global Antibiotic Research and Development Partnership (GARDP) and key partners from 2018 to 2020, explored the outcomes of more than 3,200 newborns, finding an overall mortality of 11% in those with suspected neonatal sepsis. The mortality rate increased to 18% in newborns in whom a pathogen was detected in blood culture.

More than half of infection-related deaths (59%) were due to hospital-acquired infections. Klebsiella pneumoniae was the most common pathogen isolated and is usually associated with hospital-acquired infections, which are increasingly resistant to existing antibiotic treatments, said a report produced by GARDP to accompany the results.

The study also identified a worrying trend: Hospitals are frequently using last-line agents such as carbapenems because of the high degree of antibiotic resistance in their facilities. Of note, 15% of babies with neonatal sepsis were given last-line antibiotics.

Pediatrician Julia Bielicki, MD, PhD, senior lecturer, Paediatric Infectious Diseases Research Group, St. George’s University of London, and clinician at the University of Basel Children’s Hospital, Switzerland, was a coinvestigator on the NeoOBS study.

In an interview, she explained that, as well as reducing mortality, the research is about managing infections better to prevent long-term events and improve the quality of life for survivors of neonatal sepsis. “It can have life-changing impacts for so many babies,” Dr. Bielicki said. “Improving care is much more than just making sure the baby survives the episode of sepsis – it’s about ensuring these babies can become children and adults and go on to lead productive lives.”

Also, only a minority of patients (13%) received the World Health Organization guidelines for standard of care use of ampicillin and gentamicin, and there was increasing use of last-line agents such as carbapenems and even polymyxins in some settings in low- and middle-income countries. “This is alarming and foretells the impending crisis of a lack of antibiotics to treat sepsis caused by multidrug-resistant organisms,” according to the GARDP report.

There was wide variability in antibiotic combinations used across sites in Bangladesh, Brazil, China, Greece, India, Italy, Kenya, South Africa, Thailand, Uganda, and Vietnam, and often such use was not supported by underlying data.

Dr. Bielicki remarked that there was a shift toward broad-spectrum antibiotic use. “In a high-income country, you have more restrictive patterns of antibiotic use, but it isn’t necessarily less antibiotic exposure of neonates to antibiotics, but on the whole, usually narrow-spectrum agents are used.”

In Africa and Asia, on the other hand, clinicians often have to use a broader-spectrum antibiotic empirically and may need to switch to another antibiotic very quickly. “Sometimes alternatives are not available,” she pointed out.

“Local physicians are very perceptive of this problem of antibiotic resistance in their daily practice, especially in centers with high mortality,” said Dr. Bielicki, emphasizing that it is not their fault, but is “due to the limitations in terms of the weapons available to treat these babies, which strongly demonstrates the growing problem of antimicrobial resistance affecting these babies on a global scale.”

Tim Jinks, PhD, Head of Drug Resistant Infections Priority Program at Wellcome Trust, commented on the study in a series of text messages to this news organization. “This research provides further demonstration of the urgent need for improved treatment of newborns suffering with sepsis and particularly the requirement for new antibiotics that overcome the burden of drug-resistant infections caused by [antimicrobial resistance].”

“The study is a hugely important contribution to our understanding of the burden of neonatal sepsis in low- and middle- income countries,” he added, “and points toward ways that patient treatment can be improved to save more lives.”
 

High-, middle-, and low-income countries

The NeoOBS study gathered data from 19 hospitals in 11 high-, middle-, and low-income countries and assessed which antibiotics are currently being used to treat neonatal sepsis, as well as the degree of drug resistance associated with them. Sites included some in Italy and Greece, where most of the neonatal sepsis data currently originate, and this helped to anchor the data, Dr. Bielicki said.

The study identified babies with clinical sepsis over a 4-week period and observed how these patients were managed, particularly with respect to antibiotics, as well as outcomes including whether they recovered, remained in hospital, or died. Investigators obtained bacterial cultures from the patients and grew them to identify which organisms were causing the sepsis.

Of note, mortality varied widely between hospitals, ranging from 1% to 27%. Dr. Bielicki explained that the investigators were currently exploring the reasons behind this wide range of mortality. “There are lots of possible reasons for this, including structural factors such as how care is delivered, which is complex to measure,” she said. “It isn’t trivial to measure why, in a certain setting, mortality is low and why in another setting of comparable income range, mortality is much higher.”

Aside from the mortality results, Dr. Bielicki also emphasized that the survivors of neonatal sepsis frequently experience neurodevelopmental impacts. “A hospital may have low mortality, but many of these babies may have neurodevelopment problems, and this has a long-term impact.”

“Even though mortality might be low in a certain hospital, it might not be low in terms of morbidity,” she added.

The researchers also collected isolates from the cohort of neonates to determine which antibiotic combinations work against the pathogens. “This will help us define what sort of antibiotic regimen warrants further investigation,” Dr. Bielicki said.

Principal Investigator, Mike Sharland, MD, also from St. George’s, University of London, who is also the Antimicrobial Resistance Program Lead at Penta Child Health Research, said, in a press release, that the study had shown that antibiotic resistance is now one of the major threats to neonatal health globally. “There are virtually no studies underway on developing novel antibiotic treatments for babies with sepsis caused by multidrug-resistant infections.”

“This is a major problem for babies in all countries, both rich and poor,” he stressed.
 

NeoSep-1 trial to compare multiple different treatments

The results have paved the way for a major new global trial of multiple established and new antibiotics with the goal of reducing mortality from neonatal sepsis – the NeoSep1 trial.

“This is a randomized trial with a specific design that allows us to rank different treatments against each other in terms of effectiveness, safety, and costs,” Dr. Bielicki explained.

Among the antibiotics in the study are amikacin, flomoxef and amikacin, or fosfomycin and flomoxef in babies with sepsis 28 days old or younger. Similar to the NeoOBS study, patients will be recruited from all over the world, and in particular from low- and middle-income countries such as Kenya, South Africa, and other countries in Africa and Southeast Asia.

Ultimately, the researchers want to identify modifiable risk factors and enact change in practice. But Dr. Bielicki was quick to point out that it was difficult to disentangle those factors that can easily be changed. “Some can be changed in theory, but in practice it is actually difficult to change them. One modifiable risk factor that can be changed is probably infection control, so when resistant bacteria appear in a unit, we need to ensure that there is no or minimal transmission between babies.”

Luregn Schlapbach, MD, PhD, Head, department of intensive care and neonatology, University Children’s Hospital Zurich, Switzerland, welcomed the study, saying recent recognition of pediatric and neonatal sepsis was an urgent problem worldwide.

She referred to the 2017 WHO resolution recognizing that sepsis represents a leading cause of mortality and morbidity worldwide, affecting patients of all ages, across all continents and health care systems but that many were pediatric. “At that time, our understanding of the true burden of sepsis was limited, as was our knowledge of current epidemiology,” she said in an email interview. “The Global Burden of Disease study in 2020 revealed that about half of the approximatively 50 million global sepsis cases affect pediatric age groups, many of those during neonatal age.”

The formal acknowledgment of this extensive need emphasizes the “urgency to design preventive and therapeutic interventions to reduce this devastating burden,” Dr. Schlapbach said. “In this context, the work led by GARDP is of great importance – it is designed to improve our understanding of current practice, risk factors, and burden of neonatal sepsis across low- to middle-income settings and is essential to design adequately powered trials testing interventions such as antimicrobials to improve patient outcomes and reduce the further emergence of antimicrobial resistance.”

Dr. Bielicki and Dr. Schlapbach have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

LISBON – A shift toward broader-spectrum antibiotics and increasing antibiotic resistance has led to high levels of mortality and neurodevelopmental impacts in surviving babies, according to a large international study conducted on four continents.

Results of the 3-year study were presented at this week’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).

The observational study, NeoOBS, conducted by the Global Antibiotic Research and Development Partnership (GARDP) and key partners from 2018 to 2020, explored the outcomes of more than 3,200 newborns, finding an overall mortality of 11% in those with suspected neonatal sepsis. The mortality rate increased to 18% in newborns in whom a pathogen was detected in blood culture.

More than half of infection-related deaths (59%) were due to hospital-acquired infections. Klebsiella pneumoniae was the most common pathogen isolated and is usually associated with hospital-acquired infections, which are increasingly resistant to existing antibiotic treatments, said a report produced by GARDP to accompany the results.

The study also identified a worrying trend: Hospitals are frequently using last-line agents such as carbapenems because of the high degree of antibiotic resistance in their facilities. Of note, 15% of babies with neonatal sepsis were given last-line antibiotics.

Pediatrician Julia Bielicki, MD, PhD, senior lecturer, Paediatric Infectious Diseases Research Group, St. George’s University of London, and clinician at the University of Basel Children’s Hospital, Switzerland, was a coinvestigator on the NeoOBS study.

In an interview, she explained that, as well as reducing mortality, the research is about managing infections better to prevent long-term events and improve the quality of life for survivors of neonatal sepsis. “It can have life-changing impacts for so many babies,” Dr. Bielicki said. “Improving care is much more than just making sure the baby survives the episode of sepsis – it’s about ensuring these babies can become children and adults and go on to lead productive lives.”

Also, only a minority of patients (13%) received the World Health Organization guidelines for standard of care use of ampicillin and gentamicin, and there was increasing use of last-line agents such as carbapenems and even polymyxins in some settings in low- and middle-income countries. “This is alarming and foretells the impending crisis of a lack of antibiotics to treat sepsis caused by multidrug-resistant organisms,” according to the GARDP report.

There was wide variability in antibiotic combinations used across sites in Bangladesh, Brazil, China, Greece, India, Italy, Kenya, South Africa, Thailand, Uganda, and Vietnam, and often such use was not supported by underlying data.

Dr. Bielicki remarked that there was a shift toward broad-spectrum antibiotic use. “In a high-income country, you have more restrictive patterns of antibiotic use, but it isn’t necessarily less antibiotic exposure of neonates to antibiotics, but on the whole, usually narrow-spectrum agents are used.”

In Africa and Asia, on the other hand, clinicians often have to use a broader-spectrum antibiotic empirically and may need to switch to another antibiotic very quickly. “Sometimes alternatives are not available,” she pointed out.

“Local physicians are very perceptive of this problem of antibiotic resistance in their daily practice, especially in centers with high mortality,” said Dr. Bielicki, emphasizing that it is not their fault, but is “due to the limitations in terms of the weapons available to treat these babies, which strongly demonstrates the growing problem of antimicrobial resistance affecting these babies on a global scale.”

Tim Jinks, PhD, Head of Drug Resistant Infections Priority Program at Wellcome Trust, commented on the study in a series of text messages to this news organization. “This research provides further demonstration of the urgent need for improved treatment of newborns suffering with sepsis and particularly the requirement for new antibiotics that overcome the burden of drug-resistant infections caused by [antimicrobial resistance].”

“The study is a hugely important contribution to our understanding of the burden of neonatal sepsis in low- and middle- income countries,” he added, “and points toward ways that patient treatment can be improved to save more lives.”
 

High-, middle-, and low-income countries

The NeoOBS study gathered data from 19 hospitals in 11 high-, middle-, and low-income countries and assessed which antibiotics are currently being used to treat neonatal sepsis, as well as the degree of drug resistance associated with them. Sites included some in Italy and Greece, where most of the neonatal sepsis data currently originate, and this helped to anchor the data, Dr. Bielicki said.

The study identified babies with clinical sepsis over a 4-week period and observed how these patients were managed, particularly with respect to antibiotics, as well as outcomes including whether they recovered, remained in hospital, or died. Investigators obtained bacterial cultures from the patients and grew them to identify which organisms were causing the sepsis.

Of note, mortality varied widely between hospitals, ranging from 1% to 27%. Dr. Bielicki explained that the investigators were currently exploring the reasons behind this wide range of mortality. “There are lots of possible reasons for this, including structural factors such as how care is delivered, which is complex to measure,” she said. “It isn’t trivial to measure why, in a certain setting, mortality is low and why in another setting of comparable income range, mortality is much higher.”

Aside from the mortality results, Dr. Bielicki also emphasized that the survivors of neonatal sepsis frequently experience neurodevelopmental impacts. “A hospital may have low mortality, but many of these babies may have neurodevelopment problems, and this has a long-term impact.”

“Even though mortality might be low in a certain hospital, it might not be low in terms of morbidity,” she added.

The researchers also collected isolates from the cohort of neonates to determine which antibiotic combinations work against the pathogens. “This will help us define what sort of antibiotic regimen warrants further investigation,” Dr. Bielicki said.

Principal Investigator, Mike Sharland, MD, also from St. George’s, University of London, who is also the Antimicrobial Resistance Program Lead at Penta Child Health Research, said, in a press release, that the study had shown that antibiotic resistance is now one of the major threats to neonatal health globally. “There are virtually no studies underway on developing novel antibiotic treatments for babies with sepsis caused by multidrug-resistant infections.”

“This is a major problem for babies in all countries, both rich and poor,” he stressed.
 

NeoSep-1 trial to compare multiple different treatments

The results have paved the way for a major new global trial of multiple established and new antibiotics with the goal of reducing mortality from neonatal sepsis – the NeoSep1 trial.

“This is a randomized trial with a specific design that allows us to rank different treatments against each other in terms of effectiveness, safety, and costs,” Dr. Bielicki explained.

Among the antibiotics in the study are amikacin, flomoxef and amikacin, or fosfomycin and flomoxef in babies with sepsis 28 days old or younger. Similar to the NeoOBS study, patients will be recruited from all over the world, and in particular from low- and middle-income countries such as Kenya, South Africa, and other countries in Africa and Southeast Asia.

Ultimately, the researchers want to identify modifiable risk factors and enact change in practice. But Dr. Bielicki was quick to point out that it was difficult to disentangle those factors that can easily be changed. “Some can be changed in theory, but in practice it is actually difficult to change them. One modifiable risk factor that can be changed is probably infection control, so when resistant bacteria appear in a unit, we need to ensure that there is no or minimal transmission between babies.”

Luregn Schlapbach, MD, PhD, Head, department of intensive care and neonatology, University Children’s Hospital Zurich, Switzerland, welcomed the study, saying recent recognition of pediatric and neonatal sepsis was an urgent problem worldwide.

She referred to the 2017 WHO resolution recognizing that sepsis represents a leading cause of mortality and morbidity worldwide, affecting patients of all ages, across all continents and health care systems but that many were pediatric. “At that time, our understanding of the true burden of sepsis was limited, as was our knowledge of current epidemiology,” she said in an email interview. “The Global Burden of Disease study in 2020 revealed that about half of the approximatively 50 million global sepsis cases affect pediatric age groups, many of those during neonatal age.”

The formal acknowledgment of this extensive need emphasizes the “urgency to design preventive and therapeutic interventions to reduce this devastating burden,” Dr. Schlapbach said. “In this context, the work led by GARDP is of great importance – it is designed to improve our understanding of current practice, risk factors, and burden of neonatal sepsis across low- to middle-income settings and is essential to design adequately powered trials testing interventions such as antimicrobials to improve patient outcomes and reduce the further emergence of antimicrobial resistance.”

Dr. Bielicki and Dr. Schlapbach have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

LISBON – A shift toward broader-spectrum antibiotics and increasing antibiotic resistance has led to high levels of mortality and neurodevelopmental impacts in surviving babies, according to a large international study conducted on four continents.

Results of the 3-year study were presented at this week’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).

The observational study, NeoOBS, conducted by the Global Antibiotic Research and Development Partnership (GARDP) and key partners from 2018 to 2020, explored the outcomes of more than 3,200 newborns, finding an overall mortality of 11% in those with suspected neonatal sepsis. The mortality rate increased to 18% in newborns in whom a pathogen was detected in blood culture.

More than half of infection-related deaths (59%) were due to hospital-acquired infections. Klebsiella pneumoniae was the most common pathogen isolated and is usually associated with hospital-acquired infections, which are increasingly resistant to existing antibiotic treatments, said a report produced by GARDP to accompany the results.

The study also identified a worrying trend: Hospitals are frequently using last-line agents such as carbapenems because of the high degree of antibiotic resistance in their facilities. Of note, 15% of babies with neonatal sepsis were given last-line antibiotics.

Pediatrician Julia Bielicki, MD, PhD, senior lecturer, Paediatric Infectious Diseases Research Group, St. George’s University of London, and clinician at the University of Basel Children’s Hospital, Switzerland, was a coinvestigator on the NeoOBS study.

In an interview, she explained that, as well as reducing mortality, the research is about managing infections better to prevent long-term events and improve the quality of life for survivors of neonatal sepsis. “It can have life-changing impacts for so many babies,” Dr. Bielicki said. “Improving care is much more than just making sure the baby survives the episode of sepsis – it’s about ensuring these babies can become children and adults and go on to lead productive lives.”

Also, only a minority of patients (13%) received the World Health Organization guidelines for standard of care use of ampicillin and gentamicin, and there was increasing use of last-line agents such as carbapenems and even polymyxins in some settings in low- and middle-income countries. “This is alarming and foretells the impending crisis of a lack of antibiotics to treat sepsis caused by multidrug-resistant organisms,” according to the GARDP report.

There was wide variability in antibiotic combinations used across sites in Bangladesh, Brazil, China, Greece, India, Italy, Kenya, South Africa, Thailand, Uganda, and Vietnam, and often such use was not supported by underlying data.

Dr. Bielicki remarked that there was a shift toward broad-spectrum antibiotic use. “In a high-income country, you have more restrictive patterns of antibiotic use, but it isn’t necessarily less antibiotic exposure of neonates to antibiotics, but on the whole, usually narrow-spectrum agents are used.”

In Africa and Asia, on the other hand, clinicians often have to use a broader-spectrum antibiotic empirically and may need to switch to another antibiotic very quickly. “Sometimes alternatives are not available,” she pointed out.

“Local physicians are very perceptive of this problem of antibiotic resistance in their daily practice, especially in centers with high mortality,” said Dr. Bielicki, emphasizing that it is not their fault, but is “due to the limitations in terms of the weapons available to treat these babies, which strongly demonstrates the growing problem of antimicrobial resistance affecting these babies on a global scale.”

Tim Jinks, PhD, Head of Drug Resistant Infections Priority Program at Wellcome Trust, commented on the study in a series of text messages to this news organization. “This research provides further demonstration of the urgent need for improved treatment of newborns suffering with sepsis and particularly the requirement for new antibiotics that overcome the burden of drug-resistant infections caused by [antimicrobial resistance].”

“The study is a hugely important contribution to our understanding of the burden of neonatal sepsis in low- and middle- income countries,” he added, “and points toward ways that patient treatment can be improved to save more lives.”
 

High-, middle-, and low-income countries

The NeoOBS study gathered data from 19 hospitals in 11 high-, middle-, and low-income countries and assessed which antibiotics are currently being used to treat neonatal sepsis, as well as the degree of drug resistance associated with them. Sites included some in Italy and Greece, where most of the neonatal sepsis data currently originate, and this helped to anchor the data, Dr. Bielicki said.

The study identified babies with clinical sepsis over a 4-week period and observed how these patients were managed, particularly with respect to antibiotics, as well as outcomes including whether they recovered, remained in hospital, or died. Investigators obtained bacterial cultures from the patients and grew them to identify which organisms were causing the sepsis.

Of note, mortality varied widely between hospitals, ranging from 1% to 27%. Dr. Bielicki explained that the investigators were currently exploring the reasons behind this wide range of mortality. “There are lots of possible reasons for this, including structural factors such as how care is delivered, which is complex to measure,” she said. “It isn’t trivial to measure why, in a certain setting, mortality is low and why in another setting of comparable income range, mortality is much higher.”

Aside from the mortality results, Dr. Bielicki also emphasized that the survivors of neonatal sepsis frequently experience neurodevelopmental impacts. “A hospital may have low mortality, but many of these babies may have neurodevelopment problems, and this has a long-term impact.”

“Even though mortality might be low in a certain hospital, it might not be low in terms of morbidity,” she added.

The researchers also collected isolates from the cohort of neonates to determine which antibiotic combinations work against the pathogens. “This will help us define what sort of antibiotic regimen warrants further investigation,” Dr. Bielicki said.

Principal Investigator, Mike Sharland, MD, also from St. George’s, University of London, who is also the Antimicrobial Resistance Program Lead at Penta Child Health Research, said, in a press release, that the study had shown that antibiotic resistance is now one of the major threats to neonatal health globally. “There are virtually no studies underway on developing novel antibiotic treatments for babies with sepsis caused by multidrug-resistant infections.”

“This is a major problem for babies in all countries, both rich and poor,” he stressed.
 

NeoSep-1 trial to compare multiple different treatments

The results have paved the way for a major new global trial of multiple established and new antibiotics with the goal of reducing mortality from neonatal sepsis – the NeoSep1 trial.

“This is a randomized trial with a specific design that allows us to rank different treatments against each other in terms of effectiveness, safety, and costs,” Dr. Bielicki explained.

Among the antibiotics in the study are amikacin, flomoxef and amikacin, or fosfomycin and flomoxef in babies with sepsis 28 days old or younger. Similar to the NeoOBS study, patients will be recruited from all over the world, and in particular from low- and middle-income countries such as Kenya, South Africa, and other countries in Africa and Southeast Asia.

Ultimately, the researchers want to identify modifiable risk factors and enact change in practice. But Dr. Bielicki was quick to point out that it was difficult to disentangle those factors that can easily be changed. “Some can be changed in theory, but in practice it is actually difficult to change them. One modifiable risk factor that can be changed is probably infection control, so when resistant bacteria appear in a unit, we need to ensure that there is no or minimal transmission between babies.”

Luregn Schlapbach, MD, PhD, Head, department of intensive care and neonatology, University Children’s Hospital Zurich, Switzerland, welcomed the study, saying recent recognition of pediatric and neonatal sepsis was an urgent problem worldwide.

She referred to the 2017 WHO resolution recognizing that sepsis represents a leading cause of mortality and morbidity worldwide, affecting patients of all ages, across all continents and health care systems but that many were pediatric. “At that time, our understanding of the true burden of sepsis was limited, as was our knowledge of current epidemiology,” she said in an email interview. “The Global Burden of Disease study in 2020 revealed that about half of the approximatively 50 million global sepsis cases affect pediatric age groups, many of those during neonatal age.”

The formal acknowledgment of this extensive need emphasizes the “urgency to design preventive and therapeutic interventions to reduce this devastating burden,” Dr. Schlapbach said. “In this context, the work led by GARDP is of great importance – it is designed to improve our understanding of current practice, risk factors, and burden of neonatal sepsis across low- to middle-income settings and is essential to design adequately powered trials testing interventions such as antimicrobials to improve patient outcomes and reduce the further emergence of antimicrobial resistance.”

Dr. Bielicki and Dr. Schlapbach have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A medication used to reduce fluid retention can also safely be used to prevent a dangerous lung condition that affects newborns, particularly those born premature, according to a new study.

Furosemide (Lasix) – which can reduce excess fluid in the body caused by heart failure, liver disease, and kidney trouble – is commonly used off-label to prevent bronchopulmonary dysplasia (BPD), a disorder that causes irritation and poor development of lungs in premature infants. But until now, researchers have not studied its safety in this setting.

BPD often affects babies born more than 2 months early and can sometimes result in breathing difficulties into adolescence and young adulthood.

“There are so few drugs that have been tested for newborns, and there are very little data to help neonatologists decide if certain medications are safe and effective,” said Rachel Greenberg, MD, MHS, a neonatologist and member of the Duke Clinical Research Institute, Durham, N.C. “We found there was no greater risk of safety events for newborns given furosemide.”

Dr. Greenberg presented the findings at the 2022 Pediatric Academic Societies meeting in Denver.

For the 28-day randomized controlled trial, Dr. Greenberg and colleagues enrolled 80 preterm newborns, born at less than 29 weeks’ gestation, at 17 centers within the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Trials Network. Of those, 61 received furosemide and 19 received a placebo.

Although babies given furosemide had more problems with electrolytes – an expected outcome from the use of diuretic medications – the researchers observed no greater risk for more serious issues, namely hearing loss or kidney stones, Dr. Greenberg told this news organization.

“The mechanism here is we know that extra fluid can damage the lungs and can cause you to have to use more respiratory support and more oxygen,” she said. “The thought from a physiological standpoint is using a diuretic can decrease fluid in the lungs and lead to improvements in lung outcomes.”

The researchers did not observe a reduction in BDP or death in babies who received furosemide, but Dr. Greenberg said the study was underpowered to detect such an effect.

“We were not powered to detect a difference in that outcome; the overall objective of this study was always to evaluate safety,” she said. “Of course, we wanted to capture variables that would measure effectiveness as well.

“Because this was a pragmatic trial, we did not limit the amount of fluids that the clinicians could give the participating infants. This could have impacted the effectiveness of furosemide. We would need a different design and larger study to truly determine effectiveness.” 

Dr. Greenberg said she hoped the new data will provide greater insight to neonatal providers and help bolster future, more large-scale trials using furosemide in premature infants.   

The drug has previously been associated with both kidney stones and ototoxicity, which occurs when medication causes a person to develop hearing or balance problems, said Nicolas Bamat, MD, MSCE, assistant professor of pediatrics at the Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Although the number of children in the latest study was too small to generate any firm conclusions, he said, the trial provides the best data to date on furosemide in premature infants.

The medication is used frequently both on babies at risk of developing BPD and babies who have already reached BPD status. Among newborns with highest risk of dying, furosemide is indeed the “most frequently used pharmacotherapy,” Dr. Bamat said.

“What’s worth noting is that furosemide is an old medication that has been used extensively in the neonatal populations for 40 years, and that is occurring in the absence of data,” Dr. Bamat added. “This is a very important step forward.”

Dr. Greenberg and Dr. Bamat have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A medication used to reduce fluid retention can also safely be used to prevent a dangerous lung condition that affects newborns, particularly those born premature, according to a new study.

Furosemide (Lasix) – which can reduce excess fluid in the body caused by heart failure, liver disease, and kidney trouble – is commonly used off-label to prevent bronchopulmonary dysplasia (BPD), a disorder that causes irritation and poor development of lungs in premature infants. But until now, researchers have not studied its safety in this setting.

BPD often affects babies born more than 2 months early and can sometimes result in breathing difficulties into adolescence and young adulthood.

“There are so few drugs that have been tested for newborns, and there are very little data to help neonatologists decide if certain medications are safe and effective,” said Rachel Greenberg, MD, MHS, a neonatologist and member of the Duke Clinical Research Institute, Durham, N.C. “We found there was no greater risk of safety events for newborns given furosemide.”

Dr. Greenberg presented the findings at the 2022 Pediatric Academic Societies meeting in Denver.

For the 28-day randomized controlled trial, Dr. Greenberg and colleagues enrolled 80 preterm newborns, born at less than 29 weeks’ gestation, at 17 centers within the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Trials Network. Of those, 61 received furosemide and 19 received a placebo.

Although babies given furosemide had more problems with electrolytes – an expected outcome from the use of diuretic medications – the researchers observed no greater risk for more serious issues, namely hearing loss or kidney stones, Dr. Greenberg told this news organization.

“The mechanism here is we know that extra fluid can damage the lungs and can cause you to have to use more respiratory support and more oxygen,” she said. “The thought from a physiological standpoint is using a diuretic can decrease fluid in the lungs and lead to improvements in lung outcomes.”

The researchers did not observe a reduction in BDP or death in babies who received furosemide, but Dr. Greenberg said the study was underpowered to detect such an effect.

“We were not powered to detect a difference in that outcome; the overall objective of this study was always to evaluate safety,” she said. “Of course, we wanted to capture variables that would measure effectiveness as well.

“Because this was a pragmatic trial, we did not limit the amount of fluids that the clinicians could give the participating infants. This could have impacted the effectiveness of furosemide. We would need a different design and larger study to truly determine effectiveness.” 

Dr. Greenberg said she hoped the new data will provide greater insight to neonatal providers and help bolster future, more large-scale trials using furosemide in premature infants.   

The drug has previously been associated with both kidney stones and ototoxicity, which occurs when medication causes a person to develop hearing or balance problems, said Nicolas Bamat, MD, MSCE, assistant professor of pediatrics at the Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Although the number of children in the latest study was too small to generate any firm conclusions, he said, the trial provides the best data to date on furosemide in premature infants.

The medication is used frequently both on babies at risk of developing BPD and babies who have already reached BPD status. Among newborns with highest risk of dying, furosemide is indeed the “most frequently used pharmacotherapy,” Dr. Bamat said.

“What’s worth noting is that furosemide is an old medication that has been used extensively in the neonatal populations for 40 years, and that is occurring in the absence of data,” Dr. Bamat added. “This is a very important step forward.”

Dr. Greenberg and Dr. Bamat have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A medication used to reduce fluid retention can also safely be used to prevent a dangerous lung condition that affects newborns, particularly those born premature, according to a new study.

Furosemide (Lasix) – which can reduce excess fluid in the body caused by heart failure, liver disease, and kidney trouble – is commonly used off-label to prevent bronchopulmonary dysplasia (BPD), a disorder that causes irritation and poor development of lungs in premature infants. But until now, researchers have not studied its safety in this setting.

BPD often affects babies born more than 2 months early and can sometimes result in breathing difficulties into adolescence and young adulthood.

“There are so few drugs that have been tested for newborns, and there are very little data to help neonatologists decide if certain medications are safe and effective,” said Rachel Greenberg, MD, MHS, a neonatologist and member of the Duke Clinical Research Institute, Durham, N.C. “We found there was no greater risk of safety events for newborns given furosemide.”

Dr. Greenberg presented the findings at the 2022 Pediatric Academic Societies meeting in Denver.

For the 28-day randomized controlled trial, Dr. Greenberg and colleagues enrolled 80 preterm newborns, born at less than 29 weeks’ gestation, at 17 centers within the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Trials Network. Of those, 61 received furosemide and 19 received a placebo.

Although babies given furosemide had more problems with electrolytes – an expected outcome from the use of diuretic medications – the researchers observed no greater risk for more serious issues, namely hearing loss or kidney stones, Dr. Greenberg told this news organization.

“The mechanism here is we know that extra fluid can damage the lungs and can cause you to have to use more respiratory support and more oxygen,” she said. “The thought from a physiological standpoint is using a diuretic can decrease fluid in the lungs and lead to improvements in lung outcomes.”

The researchers did not observe a reduction in BDP or death in babies who received furosemide, but Dr. Greenberg said the study was underpowered to detect such an effect.

“We were not powered to detect a difference in that outcome; the overall objective of this study was always to evaluate safety,” she said. “Of course, we wanted to capture variables that would measure effectiveness as well.

“Because this was a pragmatic trial, we did not limit the amount of fluids that the clinicians could give the participating infants. This could have impacted the effectiveness of furosemide. We would need a different design and larger study to truly determine effectiveness.” 

Dr. Greenberg said she hoped the new data will provide greater insight to neonatal providers and help bolster future, more large-scale trials using furosemide in premature infants.   

The drug has previously been associated with both kidney stones and ototoxicity, which occurs when medication causes a person to develop hearing or balance problems, said Nicolas Bamat, MD, MSCE, assistant professor of pediatrics at the Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Although the number of children in the latest study was too small to generate any firm conclusions, he said, the trial provides the best data to date on furosemide in premature infants.

The medication is used frequently both on babies at risk of developing BPD and babies who have already reached BPD status. Among newborns with highest risk of dying, furosemide is indeed the “most frequently used pharmacotherapy,” Dr. Bamat said.

“What’s worth noting is that furosemide is an old medication that has been used extensively in the neonatal populations for 40 years, and that is occurring in the absence of data,” Dr. Bamat added. “This is a very important step forward.”

Dr. Greenberg and Dr. Bamat have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Poverty is known to be associated with poor health outcomes throughout life. Now, new research has shown that, from as early as the second trimester of pregnancy, fetuses are already feeling the effects of poverty.

“There is a well-recognized health inequality where quality and duration of life are lower among the most poor. This divide is present both within and between countries,” said Steve Turner, who led the study.

Given the association of poverty and low birth weight, the authors of the new multi-national study, published in the Journal of Epidemiology and Community Health, hypothesized that “individuals from highest household income compared to those with lowest household income will have increased fetal size in the second and third trimester and birth.”

For their study, researchers from the University of Aberdeen gathered details of ante-natal and birth size – second and third trimester fetal ultrasound measurements of estimated fetal weight, biparietal diameter, and femur length, as well as birth measurements of weight, occipitofrontal circumference, and crown heel length – from eight cohorts that included 21,714 individuals from nations including Scotland, England, Saudi Arabia, the U.S., Netherlands, Spain, Norway, Sweden, and France.

They then related these to household income, taking into account other factors, including mother’s age, height, number of other children, and smoking, analyzing the data using cross-sectional two-stage individual patient data analyses and a longitudinal one-stage individual patient data analysis.
 

Household income closely related to birth size

The authors found that higher household income was associated with larger fetal head size and weight but not length, from the second half of pregnancy, compared with lowest household income. They said that their results argue for “a relationship where household income is closely related to birth size.”

The results showed that, across the countries studied, babies were smaller at birth if they came from a lower income household, and this discrepancy in size was already apparent at 20 weeks gestation.

“This is the first time that size differences have been found at such an early stage of development,” the authors said, “and also the first time it has been compared across continents.”

Professor Turner pointed out that “what this study shows is that the inequality, as seen by reduced size in fetal life, is present long before birth, and this poverty gap widens between twenty weeks gestation and birth.”

He added: “Basically, regardless of whether you live in Saudi, the U.S., or Europe, and accounting for things that might affect fetal growth, if your parents are poor, you will be smaller before birth and at birth compared to if your parents were not poor.”
 

Increase engagement with pregnant mothers living in poverty

He emphasized how this was problematic, as small size before and after birth puts an individual at “increased risk for many serious illnesses in later life.”

The authors hope that this study will encourage health care providers to recognize the health risks associated with lower income for mothers and their unborn children and to provide more support and guidance to mitigate the risks.

They said, “interventions aimed at softening the impact of poverty on pregnant mothers could reduce incidence of small for gestational age and the associated burden of excessive morbidity and mortality throughout the life course.”

Professor Turner described how the mechanisms that drive this inequity may be explained by pregnant mothers from poor households having difficulty in accessing or engaging with antenatal care. 

“We would like to see health care providers around the world strive to increase engagement with pregnant mothers living in poverty,” he said. “This engagement will reward all of society by putting unborn children on a trajectory to longer and healthier lives.”

A version of this article first appeared on Medscape UK.

Poverty is known to be associated with poor health outcomes throughout life. Now, new research has shown that, from as early as the second trimester of pregnancy, fetuses are already feeling the effects of poverty.

“There is a well-recognized health inequality where quality and duration of life are lower among the most poor. This divide is present both within and between countries,” said Steve Turner, who led the study.

Given the association of poverty and low birth weight, the authors of the new multi-national study, published in the Journal of Epidemiology and Community Health, hypothesized that “individuals from highest household income compared to those with lowest household income will have increased fetal size in the second and third trimester and birth.”

For their study, researchers from the University of Aberdeen gathered details of ante-natal and birth size – second and third trimester fetal ultrasound measurements of estimated fetal weight, biparietal diameter, and femur length, as well as birth measurements of weight, occipitofrontal circumference, and crown heel length – from eight cohorts that included 21,714 individuals from nations including Scotland, England, Saudi Arabia, the U.S., Netherlands, Spain, Norway, Sweden, and France.

They then related these to household income, taking into account other factors, including mother’s age, height, number of other children, and smoking, analyzing the data using cross-sectional two-stage individual patient data analyses and a longitudinal one-stage individual patient data analysis.
 

Household income closely related to birth size

The authors found that higher household income was associated with larger fetal head size and weight but not length, from the second half of pregnancy, compared with lowest household income. They said that their results argue for “a relationship where household income is closely related to birth size.”

The results showed that, across the countries studied, babies were smaller at birth if they came from a lower income household, and this discrepancy in size was already apparent at 20 weeks gestation.

“This is the first time that size differences have been found at such an early stage of development,” the authors said, “and also the first time it has been compared across continents.”

Professor Turner pointed out that “what this study shows is that the inequality, as seen by reduced size in fetal life, is present long before birth, and this poverty gap widens between twenty weeks gestation and birth.”

He added: “Basically, regardless of whether you live in Saudi, the U.S., or Europe, and accounting for things that might affect fetal growth, if your parents are poor, you will be smaller before birth and at birth compared to if your parents were not poor.”
 

Increase engagement with pregnant mothers living in poverty

He emphasized how this was problematic, as small size before and after birth puts an individual at “increased risk for many serious illnesses in later life.”

The authors hope that this study will encourage health care providers to recognize the health risks associated with lower income for mothers and their unborn children and to provide more support and guidance to mitigate the risks.

They said, “interventions aimed at softening the impact of poverty on pregnant mothers could reduce incidence of small for gestational age and the associated burden of excessive morbidity and mortality throughout the life course.”

Professor Turner described how the mechanisms that drive this inequity may be explained by pregnant mothers from poor households having difficulty in accessing or engaging with antenatal care. 

“We would like to see health care providers around the world strive to increase engagement with pregnant mothers living in poverty,” he said. “This engagement will reward all of society by putting unborn children on a trajectory to longer and healthier lives.”

A version of this article first appeared on Medscape UK.

Poverty is known to be associated with poor health outcomes throughout life. Now, new research has shown that, from as early as the second trimester of pregnancy, fetuses are already feeling the effects of poverty.

“There is a well-recognized health inequality where quality and duration of life are lower among the most poor. This divide is present both within and between countries,” said Steve Turner, who led the study.

Given the association of poverty and low birth weight, the authors of the new multi-national study, published in the Journal of Epidemiology and Community Health, hypothesized that “individuals from highest household income compared to those with lowest household income will have increased fetal size in the second and third trimester and birth.”

For their study, researchers from the University of Aberdeen gathered details of ante-natal and birth size – second and third trimester fetal ultrasound measurements of estimated fetal weight, biparietal diameter, and femur length, as well as birth measurements of weight, occipitofrontal circumference, and crown heel length – from eight cohorts that included 21,714 individuals from nations including Scotland, England, Saudi Arabia, the U.S., Netherlands, Spain, Norway, Sweden, and France.

They then related these to household income, taking into account other factors, including mother’s age, height, number of other children, and smoking, analyzing the data using cross-sectional two-stage individual patient data analyses and a longitudinal one-stage individual patient data analysis.
 

Household income closely related to birth size

The authors found that higher household income was associated with larger fetal head size and weight but not length, from the second half of pregnancy, compared with lowest household income. They said that their results argue for “a relationship where household income is closely related to birth size.”

The results showed that, across the countries studied, babies were smaller at birth if they came from a lower income household, and this discrepancy in size was already apparent at 20 weeks gestation.

“This is the first time that size differences have been found at such an early stage of development,” the authors said, “and also the first time it has been compared across continents.”

Professor Turner pointed out that “what this study shows is that the inequality, as seen by reduced size in fetal life, is present long before birth, and this poverty gap widens between twenty weeks gestation and birth.”

He added: “Basically, regardless of whether you live in Saudi, the U.S., or Europe, and accounting for things that might affect fetal growth, if your parents are poor, you will be smaller before birth and at birth compared to if your parents were not poor.”
 

Increase engagement with pregnant mothers living in poverty

He emphasized how this was problematic, as small size before and after birth puts an individual at “increased risk for many serious illnesses in later life.”

The authors hope that this study will encourage health care providers to recognize the health risks associated with lower income for mothers and their unborn children and to provide more support and guidance to mitigate the risks.

They said, “interventions aimed at softening the impact of poverty on pregnant mothers could reduce incidence of small for gestational age and the associated burden of excessive morbidity and mortality throughout the life course.”

Professor Turner described how the mechanisms that drive this inequity may be explained by pregnant mothers from poor households having difficulty in accessing or engaging with antenatal care. 

“We would like to see health care providers around the world strive to increase engagement with pregnant mothers living in poverty,” he said. “This engagement will reward all of society by putting unborn children on a trajectory to longer and healthier lives.”

A version of this article first appeared on Medscape UK.

For a decade, the number of babies born with syphilis in the United States has surged, undeterred. Data released Apr. 12 by the Centers for Disease Control and Prevention shows just how dire the outbreak has become.

In 2012, 332 babies were born infected with the disease. In 2021, that number had climbed nearly sevenfold, to at least 2,268, according to preliminary estimates. And 166 of those babies died.

About 7% of babies diagnosed with syphilis in recent years have died; thousands of others born with the disease have faced problems that include brain and bone malformations, blindness, and organ damage.

For public health officials, the situation is all the more heartbreaking, considering that congenital syphilis rates reached near-historic modern lows from 2000 to 2012 amid ambitious prevention and education efforts. By 2020, following a sharp erosion in funding and attention, the nationwide case rate was more than seven times that of 2012.

“The really depressing thing about it is we had this thing virtually eradicated back in the year 2000,” said William Andrews, a public information officer for Oklahoma’s sexual health and harm reduction service. “Now it’s back with a vengeance. We are really trying to get the message out that sexual health is health. It’s nothing to be ashamed of.”

Even as caseloads soar, the CDC budget for STD prevention – the primary funding source for most public health departments – has been largely stagnant for two decades, its purchasing power dragged even lower by inflation.

The CDC report on STD trends provides official data on congenital syphilis cases for 2020, as well as preliminary case counts for 2021 that are expected to increase. CDC data shows that congenital syphilis rates in 2020 continued to climb in already overwhelmed states like Texas, California, and Nevada and that the disease is now present in almost every state in the nation. All but three states – Maine, New Hampshire, and Vermont – reported congenital syphilis cases in 2020.

From 2011 to 2020, congenital syphilis resulted in 633 documented stillbirths and infant deaths, according to the new CDC data.

Preventing congenital syphilis – the term used when syphilis is transferred to a fetus in utero – is from a medical standpoint exceedingly simple: If a pregnant woman is diagnosed at least a month before giving birth, just a few shots of penicillin have a near-perfect cure rate for mother and baby. But funding cuts and competing priorities in the nation’s fragmented public health care system have vastly narrowed access to such services.

The reasons pregnant people with syphilis go undiagnosed or untreated vary geographically, according to data collected by states and analyzed by the CDC.

In Western states, the largest share of cases involve women who have received little to no prenatal care and aren’t tested for syphilis until they give birth. Many have substance use disorders, primarily related to methamphetamines. “They’ve felt a lot of judgment and stigma by the medical community,” said Stephanie Pierce, MD, a maternal fetal medicine specialist at the University of Oklahoma, Oklahoma City, who runs a clinic for women with high-risk pregnancies.

In Southern states, a CDC study of 2018 data found that the largest share of congenital syphilis cases were among women who had been tested and diagnosed but hadn’t received treatment. That year, among Black moms who gave birth to a baby with syphilis, 37% had not been treated adequately even though they’d received a timely diagnosis. Among white moms, that number was 24%. Longstanding racism in medical care, poverty, transportation issues, poorly funded public health departments, and crowded clinics whose employees are too overworked to follow up with patients all contribute to the problem, according to infectious disease experts.

Doctors are also noticing a growing number of women who are treated for syphilis but reinfected during pregnancy. Amid rising cases and stagnant resources, some states have focused disease investigations on pregnant women of childbearing age; they can no longer prioritize treating sexual partners who are also infected.

Eric McGrath, MD, a pediatric infectious disease specialist at Wayne State University, Detroit, said that he’d seen several newborns in recent years whose mothers had been treated for syphilis but then were re-exposed during pregnancy by partners who hadn’t been treated.

Treating a newborn baby for syphilis isn’t trivial. Penicillin carries little risk, but delivering it to a baby often involves a lumbar puncture and other painful procedures. And treatment typically means keeping the baby in the hospital for 10 days, interrupting an important time for family bonding.

Dr. McGrath has seen a couple of babies in his career who weren’t diagnosed or treated at birth and later came to him with full-blown syphilis complications, including full-body rashes and inflamed livers. It was an awful experience he doesn’t want to repeat. The preferred course, he said, is to spare the baby the ordeal and treat parents early in the pregnancy.

But in some places, providers aren’t routinely testing for syphilis. Although most states mandate testing at some point during pregnancy, as of last year just 14 required it for everyone in the third trimester. The CDC recommends third-trimester testing in areas with high rates of syphilis, a growing share of the United States.

After Arizona declared a statewide outbreak in 2018, state health officials wanted to know whether widespread testing in the third trimester could have prevented infections. Looking at 18 months of data, analysts found that nearly three-quarters of the more than 200 pregnant women diagnosed with syphilis in 2017 and the first half of 2018 got treatment. That left 57 babies born with syphilis, nine of whom died. The analysts estimated that a third of the infections could have been prevented with testing in the third trimester.

Based on the numbers they saw in those 18 months, officials estimated that screening all women on Medicaid in the third trimester would cost the state $113,300 annually, and that treating all cases of syphilis that screening would catch could be done for just $113. Factoring in the hospitalization costs for infected infants, the officials concluded the additional testing would save the state money.

And yet prevention money has been hard to come by. Taking inflation into account, CDC prevention funding for STDs has fallen 41% since 2003, according to an analysis by the National Coalition of STD Directors. That’s even as cases have risen, leaving public health departments saddled with more work and far less money.

Janine Waters, STD program manager for the state of New Mexico, has watched the unraveling. When Ms. Waters started her career more than 20 years ago, she and her colleagues followed up on every case of chlamydia, gonorrhea, and syphilis reported, not only making sure that people got treatment but also getting in touch with their sexual partners, with the aim of stopping the spread of infection. In a 2019 interview with Kaiser Health News, she said her team was struggling to keep up with syphilis alone, even as they registered with dread congenital syphilis cases surging in neighboring Texas and Arizona.

By 2020, New Mexico had the highest rate of congenital syphilis in the country.

The COVID-19 pandemic drained the remaining resources. Half of health departments across the country discontinued STD fieldwork altogether, diverting their resources to COVID. In California, which for years has struggled with high rates of congenital syphilis, three-quarters of local health departments dispatched more than half of their STD staffers to work on COVID.

As the pandemic ebbs – at least in the short term – many public health departments are turning their attention back to syphilis and other diseases. And they are doing it with reinforcements. Although the Biden administration’s proposed STD prevention budget for 2023 remains flat, the American Rescue Plan Act included $200 million to help health departments boost contact tracing and surveillance for covid and other infectious diseases. Many departments are funneling that money toward STDs.

The money is an infusion that state health officials say will make a difference. But when taking inflation into account, it essentially brings STD prevention funding back to what it was in 2003, said Stephanie Arnold Pang of the National Coalition of STD Directors. And the American Rescue Plan money doesn’t cover some aspects of STD prevention, including clinical services.

The coalition wants to revive dedicated STD clinics, where people can drop in for testing and treatment at little to no cost. Advocates say that would fill a void that has plagued treatment efforts since public clinics closed en masse in the wake of the 2008 recession.

Texas, battling its own pervasive outbreak, will use its share of American Rescue Plan money to fill 94 new positions focused on various aspects of STD prevention. Those hires will bolster a range of measures the state put in place before the pandemic, including an updated data system to track infections, review boards in major cities that examine what went wrong for every case of congenital syphilis, and a requirement that providers test for syphilis during the third trimester of pregnancy. The suite of interventions seems to be working, but it could be a while before cases go down, said Amy Carter, the state’s congenital syphilis coordinator.

“The growth didn’t happen overnight,” Ms. Carter said. “So our prevention efforts aren’t going to have a direct impact overnight either.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation

For a decade, the number of babies born with syphilis in the United States has surged, undeterred. Data released Apr. 12 by the Centers for Disease Control and Prevention shows just how dire the outbreak has become.

In 2012, 332 babies were born infected with the disease. In 2021, that number had climbed nearly sevenfold, to at least 2,268, according to preliminary estimates. And 166 of those babies died.

About 7% of babies diagnosed with syphilis in recent years have died; thousands of others born with the disease have faced problems that include brain and bone malformations, blindness, and organ damage.

For public health officials, the situation is all the more heartbreaking, considering that congenital syphilis rates reached near-historic modern lows from 2000 to 2012 amid ambitious prevention and education efforts. By 2020, following a sharp erosion in funding and attention, the nationwide case rate was more than seven times that of 2012.

“The really depressing thing about it is we had this thing virtually eradicated back in the year 2000,” said William Andrews, a public information officer for Oklahoma’s sexual health and harm reduction service. “Now it’s back with a vengeance. We are really trying to get the message out that sexual health is health. It’s nothing to be ashamed of.”

Even as caseloads soar, the CDC budget for STD prevention – the primary funding source for most public health departments – has been largely stagnant for two decades, its purchasing power dragged even lower by inflation.

The CDC report on STD trends provides official data on congenital syphilis cases for 2020, as well as preliminary case counts for 2021 that are expected to increase. CDC data shows that congenital syphilis rates in 2020 continued to climb in already overwhelmed states like Texas, California, and Nevada and that the disease is now present in almost every state in the nation. All but three states – Maine, New Hampshire, and Vermont – reported congenital syphilis cases in 2020.

From 2011 to 2020, congenital syphilis resulted in 633 documented stillbirths and infant deaths, according to the new CDC data.

Preventing congenital syphilis – the term used when syphilis is transferred to a fetus in utero – is from a medical standpoint exceedingly simple: If a pregnant woman is diagnosed at least a month before giving birth, just a few shots of penicillin have a near-perfect cure rate for mother and baby. But funding cuts and competing priorities in the nation’s fragmented public health care system have vastly narrowed access to such services.

The reasons pregnant people with syphilis go undiagnosed or untreated vary geographically, according to data collected by states and analyzed by the CDC.

In Western states, the largest share of cases involve women who have received little to no prenatal care and aren’t tested for syphilis until they give birth. Many have substance use disorders, primarily related to methamphetamines. “They’ve felt a lot of judgment and stigma by the medical community,” said Stephanie Pierce, MD, a maternal fetal medicine specialist at the University of Oklahoma, Oklahoma City, who runs a clinic for women with high-risk pregnancies.

In Southern states, a CDC study of 2018 data found that the largest share of congenital syphilis cases were among women who had been tested and diagnosed but hadn’t received treatment. That year, among Black moms who gave birth to a baby with syphilis, 37% had not been treated adequately even though they’d received a timely diagnosis. Among white moms, that number was 24%. Longstanding racism in medical care, poverty, transportation issues, poorly funded public health departments, and crowded clinics whose employees are too overworked to follow up with patients all contribute to the problem, according to infectious disease experts.

Doctors are also noticing a growing number of women who are treated for syphilis but reinfected during pregnancy. Amid rising cases and stagnant resources, some states have focused disease investigations on pregnant women of childbearing age; they can no longer prioritize treating sexual partners who are also infected.

Eric McGrath, MD, a pediatric infectious disease specialist at Wayne State University, Detroit, said that he’d seen several newborns in recent years whose mothers had been treated for syphilis but then were re-exposed during pregnancy by partners who hadn’t been treated.

Treating a newborn baby for syphilis isn’t trivial. Penicillin carries little risk, but delivering it to a baby often involves a lumbar puncture and other painful procedures. And treatment typically means keeping the baby in the hospital for 10 days, interrupting an important time for family bonding.

Dr. McGrath has seen a couple of babies in his career who weren’t diagnosed or treated at birth and later came to him with full-blown syphilis complications, including full-body rashes and inflamed livers. It was an awful experience he doesn’t want to repeat. The preferred course, he said, is to spare the baby the ordeal and treat parents early in the pregnancy.

But in some places, providers aren’t routinely testing for syphilis. Although most states mandate testing at some point during pregnancy, as of last year just 14 required it for everyone in the third trimester. The CDC recommends third-trimester testing in areas with high rates of syphilis, a growing share of the United States.

After Arizona declared a statewide outbreak in 2018, state health officials wanted to know whether widespread testing in the third trimester could have prevented infections. Looking at 18 months of data, analysts found that nearly three-quarters of the more than 200 pregnant women diagnosed with syphilis in 2017 and the first half of 2018 got treatment. That left 57 babies born with syphilis, nine of whom died. The analysts estimated that a third of the infections could have been prevented with testing in the third trimester.

Based on the numbers they saw in those 18 months, officials estimated that screening all women on Medicaid in the third trimester would cost the state $113,300 annually, and that treating all cases of syphilis that screening would catch could be done for just $113. Factoring in the hospitalization costs for infected infants, the officials concluded the additional testing would save the state money.

And yet prevention money has been hard to come by. Taking inflation into account, CDC prevention funding for STDs has fallen 41% since 2003, according to an analysis by the National Coalition of STD Directors. That’s even as cases have risen, leaving public health departments saddled with more work and far less money.

Janine Waters, STD program manager for the state of New Mexico, has watched the unraveling. When Ms. Waters started her career more than 20 years ago, she and her colleagues followed up on every case of chlamydia, gonorrhea, and syphilis reported, not only making sure that people got treatment but also getting in touch with their sexual partners, with the aim of stopping the spread of infection. In a 2019 interview with Kaiser Health News, she said her team was struggling to keep up with syphilis alone, even as they registered with dread congenital syphilis cases surging in neighboring Texas and Arizona.

By 2020, New Mexico had the highest rate of congenital syphilis in the country.

The COVID-19 pandemic drained the remaining resources. Half of health departments across the country discontinued STD fieldwork altogether, diverting their resources to COVID. In California, which for years has struggled with high rates of congenital syphilis, three-quarters of local health departments dispatched more than half of their STD staffers to work on COVID.

As the pandemic ebbs – at least in the short term – many public health departments are turning their attention back to syphilis and other diseases. And they are doing it with reinforcements. Although the Biden administration’s proposed STD prevention budget for 2023 remains flat, the American Rescue Plan Act included $200 million to help health departments boost contact tracing and surveillance for covid and other infectious diseases. Many departments are funneling that money toward STDs.

The money is an infusion that state health officials say will make a difference. But when taking inflation into account, it essentially brings STD prevention funding back to what it was in 2003, said Stephanie Arnold Pang of the National Coalition of STD Directors. And the American Rescue Plan money doesn’t cover some aspects of STD prevention, including clinical services.

The coalition wants to revive dedicated STD clinics, where people can drop in for testing and treatment at little to no cost. Advocates say that would fill a void that has plagued treatment efforts since public clinics closed en masse in the wake of the 2008 recession.

Texas, battling its own pervasive outbreak, will use its share of American Rescue Plan money to fill 94 new positions focused on various aspects of STD prevention. Those hires will bolster a range of measures the state put in place before the pandemic, including an updated data system to track infections, review boards in major cities that examine what went wrong for every case of congenital syphilis, and a requirement that providers test for syphilis during the third trimester of pregnancy. The suite of interventions seems to be working, but it could be a while before cases go down, said Amy Carter, the state’s congenital syphilis coordinator.

“The growth didn’t happen overnight,” Ms. Carter said. “So our prevention efforts aren’t going to have a direct impact overnight either.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation

For a decade, the number of babies born with syphilis in the United States has surged, undeterred. Data released Apr. 12 by the Centers for Disease Control and Prevention shows just how dire the outbreak has become.

In 2012, 332 babies were born infected with the disease. In 2021, that number had climbed nearly sevenfold, to at least 2,268, according to preliminary estimates. And 166 of those babies died.

About 7% of babies diagnosed with syphilis in recent years have died; thousands of others born with the disease have faced problems that include brain and bone malformations, blindness, and organ damage.

For public health officials, the situation is all the more heartbreaking, considering that congenital syphilis rates reached near-historic modern lows from 2000 to 2012 amid ambitious prevention and education efforts. By 2020, following a sharp erosion in funding and attention, the nationwide case rate was more than seven times that of 2012.

“The really depressing thing about it is we had this thing virtually eradicated back in the year 2000,” said William Andrews, a public information officer for Oklahoma’s sexual health and harm reduction service. “Now it’s back with a vengeance. We are really trying to get the message out that sexual health is health. It’s nothing to be ashamed of.”

Even as caseloads soar, the CDC budget for STD prevention – the primary funding source for most public health departments – has been largely stagnant for two decades, its purchasing power dragged even lower by inflation.

The CDC report on STD trends provides official data on congenital syphilis cases for 2020, as well as preliminary case counts for 2021 that are expected to increase. CDC data shows that congenital syphilis rates in 2020 continued to climb in already overwhelmed states like Texas, California, and Nevada and that the disease is now present in almost every state in the nation. All but three states – Maine, New Hampshire, and Vermont – reported congenital syphilis cases in 2020.

From 2011 to 2020, congenital syphilis resulted in 633 documented stillbirths and infant deaths, according to the new CDC data.

Preventing congenital syphilis – the term used when syphilis is transferred to a fetus in utero – is from a medical standpoint exceedingly simple: If a pregnant woman is diagnosed at least a month before giving birth, just a few shots of penicillin have a near-perfect cure rate for mother and baby. But funding cuts and competing priorities in the nation’s fragmented public health care system have vastly narrowed access to such services.

The reasons pregnant people with syphilis go undiagnosed or untreated vary geographically, according to data collected by states and analyzed by the CDC.

In Western states, the largest share of cases involve women who have received little to no prenatal care and aren’t tested for syphilis until they give birth. Many have substance use disorders, primarily related to methamphetamines. “They’ve felt a lot of judgment and stigma by the medical community,” said Stephanie Pierce, MD, a maternal fetal medicine specialist at the University of Oklahoma, Oklahoma City, who runs a clinic for women with high-risk pregnancies.

In Southern states, a CDC study of 2018 data found that the largest share of congenital syphilis cases were among women who had been tested and diagnosed but hadn’t received treatment. That year, among Black moms who gave birth to a baby with syphilis, 37% had not been treated adequately even though they’d received a timely diagnosis. Among white moms, that number was 24%. Longstanding racism in medical care, poverty, transportation issues, poorly funded public health departments, and crowded clinics whose employees are too overworked to follow up with patients all contribute to the problem, according to infectious disease experts.

Doctors are also noticing a growing number of women who are treated for syphilis but reinfected during pregnancy. Amid rising cases and stagnant resources, some states have focused disease investigations on pregnant women of childbearing age; they can no longer prioritize treating sexual partners who are also infected.

Eric McGrath, MD, a pediatric infectious disease specialist at Wayne State University, Detroit, said that he’d seen several newborns in recent years whose mothers had been treated for syphilis but then were re-exposed during pregnancy by partners who hadn’t been treated.

Treating a newborn baby for syphilis isn’t trivial. Penicillin carries little risk, but delivering it to a baby often involves a lumbar puncture and other painful procedures. And treatment typically means keeping the baby in the hospital for 10 days, interrupting an important time for family bonding.

Dr. McGrath has seen a couple of babies in his career who weren’t diagnosed or treated at birth and later came to him with full-blown syphilis complications, including full-body rashes and inflamed livers. It was an awful experience he doesn’t want to repeat. The preferred course, he said, is to spare the baby the ordeal and treat parents early in the pregnancy.

But in some places, providers aren’t routinely testing for syphilis. Although most states mandate testing at some point during pregnancy, as of last year just 14 required it for everyone in the third trimester. The CDC recommends third-trimester testing in areas with high rates of syphilis, a growing share of the United States.

After Arizona declared a statewide outbreak in 2018, state health officials wanted to know whether widespread testing in the third trimester could have prevented infections. Looking at 18 months of data, analysts found that nearly three-quarters of the more than 200 pregnant women diagnosed with syphilis in 2017 and the first half of 2018 got treatment. That left 57 babies born with syphilis, nine of whom died. The analysts estimated that a third of the infections could have been prevented with testing in the third trimester.

Based on the numbers they saw in those 18 months, officials estimated that screening all women on Medicaid in the third trimester would cost the state $113,300 annually, and that treating all cases of syphilis that screening would catch could be done for just $113. Factoring in the hospitalization costs for infected infants, the officials concluded the additional testing would save the state money.

And yet prevention money has been hard to come by. Taking inflation into account, CDC prevention funding for STDs has fallen 41% since 2003, according to an analysis by the National Coalition of STD Directors. That’s even as cases have risen, leaving public health departments saddled with more work and far less money.

Janine Waters, STD program manager for the state of New Mexico, has watched the unraveling. When Ms. Waters started her career more than 20 years ago, she and her colleagues followed up on every case of chlamydia, gonorrhea, and syphilis reported, not only making sure that people got treatment but also getting in touch with their sexual partners, with the aim of stopping the spread of infection. In a 2019 interview with Kaiser Health News, she said her team was struggling to keep up with syphilis alone, even as they registered with dread congenital syphilis cases surging in neighboring Texas and Arizona.

By 2020, New Mexico had the highest rate of congenital syphilis in the country.

The COVID-19 pandemic drained the remaining resources. Half of health departments across the country discontinued STD fieldwork altogether, diverting their resources to COVID. In California, which for years has struggled with high rates of congenital syphilis, three-quarters of local health departments dispatched more than half of their STD staffers to work on COVID.

As the pandemic ebbs – at least in the short term – many public health departments are turning their attention back to syphilis and other diseases. And they are doing it with reinforcements. Although the Biden administration’s proposed STD prevention budget for 2023 remains flat, the American Rescue Plan Act included $200 million to help health departments boost contact tracing and surveillance for covid and other infectious diseases. Many departments are funneling that money toward STDs.

The money is an infusion that state health officials say will make a difference. But when taking inflation into account, it essentially brings STD prevention funding back to what it was in 2003, said Stephanie Arnold Pang of the National Coalition of STD Directors. And the American Rescue Plan money doesn’t cover some aspects of STD prevention, including clinical services.

The coalition wants to revive dedicated STD clinics, where people can drop in for testing and treatment at little to no cost. Advocates say that would fill a void that has plagued treatment efforts since public clinics closed en masse in the wake of the 2008 recession.

Texas, battling its own pervasive outbreak, will use its share of American Rescue Plan money to fill 94 new positions focused on various aspects of STD prevention. Those hires will bolster a range of measures the state put in place before the pandemic, including an updated data system to track infections, review boards in major cities that examine what went wrong for every case of congenital syphilis, and a requirement that providers test for syphilis during the third trimester of pregnancy. The suite of interventions seems to be working, but it could be a while before cases go down, said Amy Carter, the state’s congenital syphilis coordinator.

“The growth didn’t happen overnight,” Ms. Carter said. “So our prevention efforts aren’t going to have a direct impact overnight either.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation

The Food and Drug Administration has recommended thyroid monitoring for newborns and children through 3 years of age within 3 weeks of receiving injections of iodine-containing contrast media as part of imaging procedures.

A recent FDA review showed that “underactive thyroid or a temporary decrease in thyroid hormone levels were uncommon,” according to an updated Drug Safety Communication issued on March 30, 2022.

However, early monitoring will help identify and treat any thyroid abnormalities as a result of the injections to help prevent potential complications in the future, according to the FDA, as babies and children do not generally show visible signs of thyroid problems and may not do so after an iodinated contrast media (ICM) injection.

ICM have been approved and used for decades to enhance images on x-rays or computed tomography (CT) scans, according to the communication.

The new FDA warning and recommendation for monitoring applies to the prescribing information for the entire class of ICM products. The new communication is an update to the 2015 Drug Safety Communication that advised medical professionals of the potential for underactive thyroid in response to ICM injections in newborns and young children. The update reflects new studies since that time.

The recent research showed that most reported cases of adverse effects were transient subclinical hypothyroidism and did not require treatment, according to the FDA. “The reported rate ranged from 1 percent to 15 percent and tended to be higher in neonates, particularly preterm neonates,” they said. Others at increased risk are those with underlying medical conditions, especially those with cardiac conditions who often require higher doses of contrast during invasive procedures.

In the recent studies, the time from ICM exposure to a diagnosis of thyroid dysfunction ranged from 8.5 to 138 days, but most occurred within 3 weeks, according to the update.

Patients and clinicians can report any adverse events from ICM or other medications to the FDA via FDA MedWatch program.

For more information, read the complete Drug Safety Communication.

The Food and Drug Administration has recommended thyroid monitoring for newborns and children through 3 years of age within 3 weeks of receiving injections of iodine-containing contrast media as part of imaging procedures.

A recent FDA review showed that “underactive thyroid or a temporary decrease in thyroid hormone levels were uncommon,” according to an updated Drug Safety Communication issued on March 30, 2022.

However, early monitoring will help identify and treat any thyroid abnormalities as a result of the injections to help prevent potential complications in the future, according to the FDA, as babies and children do not generally show visible signs of thyroid problems and may not do so after an iodinated contrast media (ICM) injection.

ICM have been approved and used for decades to enhance images on x-rays or computed tomography (CT) scans, according to the communication.

The new FDA warning and recommendation for monitoring applies to the prescribing information for the entire class of ICM products. The new communication is an update to the 2015 Drug Safety Communication that advised medical professionals of the potential for underactive thyroid in response to ICM injections in newborns and young children. The update reflects new studies since that time.

The recent research showed that most reported cases of adverse effects were transient subclinical hypothyroidism and did not require treatment, according to the FDA. “The reported rate ranged from 1 percent to 15 percent and tended to be higher in neonates, particularly preterm neonates,” they said. Others at increased risk are those with underlying medical conditions, especially those with cardiac conditions who often require higher doses of contrast during invasive procedures.

In the recent studies, the time from ICM exposure to a diagnosis of thyroid dysfunction ranged from 8.5 to 138 days, but most occurred within 3 weeks, according to the update.

Patients and clinicians can report any adverse events from ICM or other medications to the FDA via FDA MedWatch program.

For more information, read the complete Drug Safety Communication.

The Food and Drug Administration has recommended thyroid monitoring for newborns and children through 3 years of age within 3 weeks of receiving injections of iodine-containing contrast media as part of imaging procedures.

A recent FDA review showed that “underactive thyroid or a temporary decrease in thyroid hormone levels were uncommon,” according to an updated Drug Safety Communication issued on March 30, 2022.

However, early monitoring will help identify and treat any thyroid abnormalities as a result of the injections to help prevent potential complications in the future, according to the FDA, as babies and children do not generally show visible signs of thyroid problems and may not do so after an iodinated contrast media (ICM) injection.

ICM have been approved and used for decades to enhance images on x-rays or computed tomography (CT) scans, according to the communication.

The new FDA warning and recommendation for monitoring applies to the prescribing information for the entire class of ICM products. The new communication is an update to the 2015 Drug Safety Communication that advised medical professionals of the potential for underactive thyroid in response to ICM injections in newborns and young children. The update reflects new studies since that time.

The recent research showed that most reported cases of adverse effects were transient subclinical hypothyroidism and did not require treatment, according to the FDA. “The reported rate ranged from 1 percent to 15 percent and tended to be higher in neonates, particularly preterm neonates,” they said. Others at increased risk are those with underlying medical conditions, especially those with cardiac conditions who often require higher doses of contrast during invasive procedures.

In the recent studies, the time from ICM exposure to a diagnosis of thyroid dysfunction ranged from 8.5 to 138 days, but most occurred within 3 weeks, according to the update.

Patients and clinicians can report any adverse events from ICM or other medications to the FDA via FDA MedWatch program.

For more information, read the complete Drug Safety Communication.