Editorials

Helmet therapy for positional plagiocephaly and brachycephaly

BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g2906 (Published 01 May 2014) Cite this as: BMJ 2014;348:g2906
  1. Brent R Collett, assistant professor
  1. 1Seattle Children’s Research Institute, PO Box 5371, Mailstop CW8-6, Seattle, WA 98145, USA
  1. bcollett{at}uw.edu

Negligible treatment effects in the first randomized evaluation

Positional plagiocephaly and brachycephaly affects approximately 20% of infants and is the most common reason for referral in many craniofacial centers.1 2 This reflects an increase in the incidence of the condition after several countries implemented public health campaigns that encouraged parents to position their babies in a supine position for sleep to prevent sudden infant death syndrome. The advent and marketing of orthotic treatments for positional plagiocephaly and brachycephaly has also likely increased awareness of plagiocephaly among parents and medical professionals. Although the persistence and implications of infant skull deformities are unclear, often parents are concerned about outcomes for their child and are motivated to participate in treatment. Previous studies showed improvements in head shape after orthotic treatment3; however, until the study by van Wijk and colleagues (doi:10.1136/bmj.g2741) published in this issue of The BMJ,4 there were no randomized controlled trials showing the efficacy of orthotic treatment compared with no treatment.

In addition to the sheer number of children affected by positional plagiocephaly and brachycephaly, several factors make van Wijk and colleagues’ study important. Earlier longitudinal studies showed that to some extent the head shape of affected children improved with no treatment.3 Thus at a minimum parents would want to know whether treatment would result in improvements above and beyond what would be expected by doing nothing at all. This is particularly true given the burdens of orthotic treatment, including the cost (which is often not covered by insurance) and the requirement that infants wear the helmet for 23 hours a day, seven days a week. For many families these costs would be tolerable if it meant an improved outcome. Unfortunately though, the findings by van Wijk and colleagues suggest virtually no treatment effect.

The authors acknowledge the limitations of this trial, and there are several important next steps for future research. The participation rate (21%) in the randomized controlled trial was low, and in fact limited participation is a barrier that has precluded other groups from attempting a similar study. Parents interested in their child receiving orthotic treatment for positional plagiocephaly and brachycephaly are understandably reluctant to have that decision randomized. Baseline personal and clinical characteristics were similar in participants and non-participants, suggesting that those who received treatment are similar to the larger population, though differences in unmeasured characteristics are possible. Although statistical power to detect differences was adequate, the sample was too small to examine possible differences between subgroups. Future studies, including larger samples, would be helpful in determining whether some infants respond more favorably than others. In particular it would be of interest to learn whether children with the most severe positional plagiocephaly and brachycephaly, who were excluded from this trial, show meaningful improvement. Finally, the measure of compliance with treatment was by parent report after the completion of helmet therapy. Objective measures, ideally provided throughout treatment, would strengthen the argument that parents use the orthotic helmet as intended and provide some insight into any “dosage” effects.

It is worth highlighting that in neither group in this study did head shape “normalize” by the end of the trial. Full recovery was achieved by only 26% and 23% of the treatment and control infants, respectively. The longer term implications of persistent positional plagiocephaly and brachycephaly remain to be shown. However, this finding argues for studies focusing on primary prevention of the condition and novel strategies to ameliorate skull deformation once it develops in early infancy. Admittedly, such efforts have not been particularly encouraging thus far.3 However, additional work incorporating behavioral and public health strategies to promote “tummy time” and similar positioning strategies should be explored. Further, in previous papers we have argued that positional plagiocephaly and brachycephaly might serve as a marker for risk of developmental problems.5 6 Identifying skull deformities early and providing intervention to facilitate development (for example, targeting deficits in early motor function, when present) may have the dual benefit of tackling positional plagiocephaly and brachycephaly and enhancing other areas of development.

Notes

Cite this as: BMJ 2014;348:g2906

Footnotes

  • Research, doi:10.1136/bmj.g2741
  • Competing interests: I have read and understood the BMJ Group policy on declaration of interests and declare the following interests: none.

  • Provenance and peer review: Commissioned, not externally peer reviewed

References