Department Health Technology and Services Research, Institute of Innovation and Governance Studies, University of Twente, Drienerlolaan 5, 7522 NB, Enschede, Netherlands.
BMJ. 2014 May 1;348:g2741. doi: 10.1136/bmj.g2741.
To determine the effectiveness of helmet therapy for positional skull deformation compared with the natural course of the condition in infants aged 5-6 months.
Pragmatic, single blinded, randomised controlled trial (HEADS, HElmet therapy Assessment in Deformed Skulls) nested in a prospective cohort study.
29 paediatric physiotherapy practices; helmet therapy was administered at four specialised centres.
84 infants aged 5 to 6 months with moderate to severe skull deformation, who were born after 36 weeks of gestation and had no muscular torticollis, craniosynostosis, or dysmorphic features. Participants were randomly assigned to helmet therapy (n=42) or to natural course of the condition (n=42) according to a randomisation plan with blocks of eight.
Six months of helmet therapy compared with the natural course of skull deformation. In both trial arms parents were asked to avoid any (additional) treatment for the skull deformation.
The primary outcome was change in skull shape from baseline to 24 months of age assessed using plagiocephalometry (anthropometric measurement instrument). Change scores for plagiocephaly (oblique diameter difference index) and brachycephaly (cranioproportional index) were each included in an analysis of covariance, using baseline values as the covariate. Secondary outcomes were ear deviation, facial asymmetry, occipital lift, and motor development in the infant, quality of life (infant and parent measures), and parental satisfaction and anxiety. Baseline measurements were performed in infants aged between 5 and 6 months, with follow-up measurements at 8, 12, and 24 months. Primary outcome assessment at 24 months was blinded.
The change score for both plagiocephaly and brachycephaly was equal between the helmet therapy and natural course groups, with a mean difference of -0.2 (95% confidence interval -1.6 to 1.2, P=0.80) and 0.2 (-1.7 to 2.2, P=0.81), respectively. Full recovery was achieved in 10 of 39 (26%) participants in the helmet therapy group and 9 of 40 (23%) participants in the natural course group (odds ratio 1.2, 95% confidence interval 0.4 to 3.3, P=0.74). All parents reported one or more side effects.
Based on the equal effectiveness of helmet therapy and skull deformation following its natural course, high prevalence of side effects, and high costs associated with helmet therapy, we discourage the use of a helmet as a standard treatment for healthy infants with moderate to severe skull deformation.
Current Controlled Trials ISRCTN18473161.
比较 5-6 月龄婴儿头盔治疗与自然病程对位置性颅骨变形的效果。
实用、单盲、随机对照试验（HEADS，畸形颅骨头盔治疗评估）嵌套在前瞻性队列研究中。
29 家儿科物理治疗诊所；头盔治疗在四个专门中心进行。
84 名 5 至 6 个月大的婴儿，颅骨变形程度为中度至重度，胎龄 36 周以上，无肌肉性斜颈、颅缝早闭或畸形特征。根据具有 8 个块的随机分组计划，将参与者随机分配至头盔治疗组（n=42）或自然病程组（n=42）。
6 个月的头盔治疗与颅骨变形的自然病程相比。在两个试验臂中，均要求父母避免对颅骨变形进行任何（额外的）治疗。
主要结局是使用平面颅测量法（人体测量仪器）评估从基线到 24 个月龄时颅骨形状的变化。偏头（斜径差指数）和短头（颅比例指数）的变化分数均包含在协方差分析中，使用基线值作为协变量。次要结局为耳偏斜、面部不对称、枕部隆起和婴儿运动发育、婴儿和父母的生活质量以及父母满意度和焦虑。在 5 至 6 个月龄的婴儿中进行基线测量，在 8、12 和 24 个月时进行随访测量。24 个月时的主要结局评估是盲法的。
头盔治疗组和自然病程组的偏头和短头的变化分数相等，差异分别为-0.2（95%置信区间-1.6 至 1.2，P=0.80）和 0.2（-1.7 至 2.2，P=0.81）。头盔治疗组有 10/39（26%）的参与者和自然病程组有 9/40（23%）的参与者完全恢复（比值比 1.2，95%置信区间 0.4 至 3.3，P=0.74）。所有父母都报告了一种或多种副作用。
根据头盔治疗与颅骨变形自然病程的同等效果、高副作用发生率以及与头盔治疗相关的高成本，我们不鼓励将头盔作为健康中重度颅骨变形婴儿的标准治疗方法。
当前对照试验 ISRCTN83165156。
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