Feasibility of a pilot randomized controlled trial on cranial remolding orthosis for severe deformational plagiocephaly.

backgroundPrevalence of deformational plagiocephaly (DP) has increased since the "Back to sleep" campaign to counter sudden infant death syndrome. Cranial remolding orthosis (CRO) is commonly used to manage severe DP in infants, yet evidence from randomized controlled trials (RCT) remains limited.

objectivesThis pilot RCT aimed to assess the feasibility of a future large-scale RCT on cranial remolding orthosis for severe DP in infants aged 4 to 7 months. Specific objectives included evaluating recruitment, retention, coordination, and parental acceptability. A secondary objective was exploring trends in cranial shape outcomes between groups over 6- and 12-week periods. METHODOLOGY: Seventy-eight infants were screened at a single pediatric tertiary-care center between December 2023 and June 2024, and 31 families were approached for consent after initial clinical evaluation. Following consent, head shape severity was assessed using three-dimensional surface imaging, and seven infants were excluded prior to randomization due to insufficient severity. Twenty-four infants were randomized to receive immediate (n = 12) or delayed (six-week delay) (n = 12) CRO. One participant randomized to the delayed arm received the orthosis earlier than planned due to a protocol deviation. Feasibility metrics included recruitment timelines, protocol adherence, appointment coordination, and parental acceptability. Exploratory efficacy analyses evaluated cranial vault asymmetry (CVA), cranial vault asymmetry index (CVAI), oblique diameter diagonal difference (ODDI), cranioproportional index (CI), Argenta severity scores, and parent-reported head shape perception and satisfaction.

findingsOf the 24 randomized infants, 20 were male and four were female. Mean age at enrollment was 5.3 ± 0.9 months in the intervention arm and 5.1 ± 0.9 months in the control arm. Recruitment and retention targets were met within seven months despite scheduling challenges. Parental satisfaction was high (mean score of 4.5 ± 0.1 on a 5-point scale), and all families reported willingness to repeat treatment despite common but minor side effects, including sweating, orthosis odor, and mild skin irritation. Significant improvements over time were observed in CVA, ODDI, and CI (all p < 0.001), with no significant between-group differences observed at 6 or 12 weeks.

conclusionThis pilot trial confirmed the feasibility and acceptability of conducting a larger RCT on CRO for DP, demonstrating successful recruitment, retention, and protocol implementation. Cranial symmetry improved over time in both groups, with no statistically significant differences observed between immediate and delayed treatment arms over the 12-week period. Future larger studies are needed to assess clinical effectiveness and should consider broader inclusion criteria, refined measurement techniques, and dedicated coordination to address scheduling challenges and ensure rigorous implementation and generalizability.