Helmets: No help, some harm
In this single-blind RCT of 84 infants (ages 5 or 6 months) with moderate or severe PSD, helmet therapy (n = 42) was compared to no intervention (allowing natural growth; n = 42). Infants were excluded if they had very severe PSD or skull deformity from another cause, such as torticollis or craniosynostosis.
Infants in the helmet therapy group received a custom-made helmet that they wore 23 hours a day until age 1 year, with regular evaluation by an orthotist and modification of the helmet as necessary to allow skull growth. The control group received usual care and no helmet.
The primary outcome was improvement in skull shape at age 24 months, as measured by the oblique diameter difference index (ODDI; a unitless measurement of plagiocephaly calculated as the ratio of measures of two dimensions of cranial diameter) and the cranioproportional index (CPI; a similar measurement of brachycephaly). Infants were considered fully recovered if they achieved an ODDI score < 104% and a CPI score < 90%. These scores indicate a normal head shape; higher scores indicate worse PSD.
At study’s end, the reduction in ODDI and CPI scores was almost the same in both groups. Ten children in the helmet group (26%) and nine in the control group (23%) experienced complete resolution of their PSD.
Both groups were similar in secondary outcomes of infant motor development, infant quality of life, and parental satisfaction. Parental anxiety was assessed using the Spielberger State-Trait Anxiety Inventory (scores range from 20 to 80; a higher score indicates greater anxiety). There was less parental anxiety in the helmet therapy group (–3.9).
All parents of infants in the helmet therapy group reported at least one adverse effect from the intervention. These effects included skin irritation (96%), bad helmet odor (76%), pain associated with the helmet (33%), and feeling hindered from cuddling their child (77%).
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