Evaluation of the Molding Helmet Therapy for Japanese Infants with Deformational Plagiocephaly

INTRODUCTION: Deformational plagiocephaly (DP) is cranial flattening on one side of the back of the skull produced by an extrinsic force on the intrinsically normal skull. When the flattening is symmetrical, the deformity is called deformational brachycephaly (DB). In the US, its prevalence has increased since the “Back to Sleep” campaign by the American Association of Pediatrics. Helmet therapy is reported to be effective in improving head deformity by multiple studies, but there are few evidences from Japan. The purpose of this study is to investigate the safety and efficacy of helmet therapy for DP, and the feasibility of introducing this treatment to the clinical setting in Japan. METHODS: This was a single-arm, retrospective, nonrandomized study. Data were collected on infants who visited the “Clinic for Baby’s Head Shape” in the National Center for Child Health and Development, Tokyo, Japan, between 2011 and 2014. Improvements in Argenta classification, cranial asymmetry (CA), and cranial vault asymmetry index (CVAI) were evaluated. The relationships between CA and influencing factors were evaluated using a linear mixed-effects model. RESULTS: Three hundred eighty-seven infants (273 boys and 114 girls; average age, 4.7 months) visited the clinic during the period, and 159 patients who completed the helmet therapy were analyzed. There were statistically significant improvements in Argenta classification, CA, and CVAI. Almost all of the parents reported increased sweating and mild skin irritation, but no adverse events necessitated the cessation of helmet therapy, except for one patient with increased sweating. CONCLUSIONS: Helmet therapy is safe and effective in treating DP and is feasible to introduce to the clinical setting in Japan. Through the distribution of knowledge regarding the etiology and treatment of head deformity, earlier detection and an evidence-based approach to head deformity are expected in the future.