Secondary outcomes included infant motor development, infant quality of life, parental satisfaction with the shape of their infant’s head, and parental anxiety. Both groups were similar in infant motor development, infant quality of life, and parental satisfaction. Parental anxiety was assessed using the Spielberger State-Trait Anxiety Inventory (scores range from 20-80; a higher score indicates greater anxiety). There was less parental anxiety in the helmet therapy group: (-3.9; 95% confidence interval, -7.5 to -0.2; P=.04).
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%).
This is the first RCT that assessed helmet therapy for PSD in children.1 Before this, the evidence on helmets for PSD had been obtained mainly from observational or poorly designed studies with significant flaws.6 This study by van Wijk et al1 included objective measurement of skull deformity, along with clinically meaningful outcomes of parental satisfaction, motor development, and parental anxiety. It also found that helmet therapy was significantly more expensive than care that focused on waiting for PSD to resolve on its own ($1935 vs $196, respectively).1
These findings do not apply to infants with very severe cases of PSD or those with skull deformity due to secondary causes, such as craniosynostosis, who were excluded from this study.1 In addition, this is the only RCT to date that has assessed helmet use in PSD, so it is possible that future studies will find helmets are effective.
To appropriately implement this recommendation, a family physician must be comfortable making the assessment of mild, moderate, severe, or very severe PSD. Referral to physical therapy might be appropriate for infants with very severe PSD.
If another physician or physical therapist recommends helmet therapy—or if a parent requests it—explaining the findings of this study may be challenging. We believe that the reduction in parental anxiety in the helmet group likely occurred because the parents believed that the helmet would accelerate the normal reshaping of the skull shape that occurs spontaneously in almost all infants with PSD. Since this study shows that helmets don’t help correct skull deformities, parents can be assured that a helmet is unnecessary, costly, and causes adverse effects.
ACKNOWLEDGEMENT
The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.