Therapeutic Effectiveness of a Novel Cranial Remolding Helmet (baby band2) for Positional Plagiocephaly: A Multicenter Clinical Observational Study

Abstract

This multicenter study evaluated the efficacy and safety of a novel cranial remolding helmet (baby band2), which is completely custom-made based on the shape of an infant’s cranium. The study included 224 full-term infants from moderate to very severe positional plagiocephaly in Japan. Cranial geometry was assessed before and after helmet therapy using a three-dimensional scanner, and changes in the cranial vault asymmetry index (CVAI) were analyzed. The CVAI improved significantly in all patients, with the most significant improvement observed in the most severely affected group [very severe group: −9.1, severe group: −6.6, moderate group: −4.4 (mean values), p < 0.001]. The group that started therapy before the age of 7 months showed greater improvement compared to those who started therapy at the age of 7 months or older; however, both groups demonstrated significant improvement (<7 months group: −6.6, ≥7 months group: −4.4 (mean values), p < 0.001). No significant differences were observed in therapy efficacy between the centers (p = 0.402) and sex (p = 0.131). During the study period, helmet therapy did not lead to head circumference stunting, and the incidence of redness with baby band2 was five patients (2.2%). This study demonstrated that baby band2 is effective and safe for the therapy of positional plagiocephaly.