BackgroundIn The Netherlands, helmet therapy is a commonly used treatment in infants with skull deformation (deformational plagiocephaly or deformational brachycephaly). However, evidence of the effectiveness of this treatment remains lacking. The HEADS study (HElmet therapy Assessment in Deformed Skulls) aims to determine the effects and costs of helmet therapy compared to no helmet therapy in infants with moderate to severe skull deformation.Methods/designPragmatic randomised controlled trial (RCT) nested in a cohort study. The cohort study included infants with a positional preference and/or skull deformation at two to four months (first assessment). At 5 months of age, all children were assessed again and infants meeting the criteria for helmet therapy were asked to participate in the RCT. Participants were randomly allocated to either helmet therapy or no helmet therapy. Parents of eligible infants that do not agree with enrolment in the RCT were invited to stay enrolled for follow up in a non-randomisedrandomised controlled trial (nRCT); they were then free to make the decision to start helmet therapy or not. Follow-up assessments took place at 8, 12 and 24 months of age. The main outcome will be head shape at 24 months that is measured using plagiocephalometry. Secondary outcomes will be satisfaction of parents and professionals with the appearance of the child, parental concerns about the future, anxiety level and satisfaction with the treatment, motor development and quality of life of the infant. Finally, compliance and costs will also be determined.DiscussionHEADS will be the first study presenting data from an RCT on the effectiveness of helmet therapy. Outcomes will be important for affected children and their parents, health care professionals and future treatment policies. Our findings are likely to influence the reimbursement policies of health insurance companies.Besides these health outcomes, we will be able to address several methodological questions, e.g. do participants in an RCT represent the eligible target population and do outcomes of the RCT differ from outcomes found in the nRCT?Trial registrationISRCTN18473161.

Vitamin D insufficiency during pregnancy is associated with disturbed skeletal homeostasis during infancy. Our aim was to investigate the influence of adherence to recommendations for vitamin D supplement intake of 10 μg per day (400 IU) during pregnancy (mother) and in the first months of life (child) on the occurrence of positional skull deformation of the child at the age of 2 to 4 months. In an observational case-control study, two hundred seventy-five 2- to 4-month-old cases with positional skull deformation were compared with 548 matched controls. A questionnaire was used to gather information on background characteristics and vitamin D intake (food, time spent outdoors and supplements). In a multiple variable logistic regression analysis, insufficient vitamin D supplement intake of women during the last trimester of pregnancy [adjusted odds ratio (aOR) 1.86, 95% (CI) 1.27-2.70] and of children during early infancy (aOR 7.15, 95% CI 3.77-13.54) were independently associated with an increased risk of skull deformation during infancy. These associations were evident after adjustment for the associations with skull deformation that were present with younger maternal age and lower maternal education, shorter pregnancy duration, assisted vaginal delivery, male gender and milk formula consumption after birth. Our findings suggest that non-adherence to recommendations for vitamin D supplement use by pregnant women and infants are associated with a higher risk of positional skull deformation in infants at 2 to 4 months of age. Our study provides an early infant life example of the importance of adequate vitamin D intake during pregnancy and infancy.

Aims To determine the effectiveness of helmet therapy compared with the natural course in children aged five months with positional skull deformation, measured at 24 months. Methods Pragmatic randomised controlled trial in 84 healthy five-month old infants with moderate to severe skull deformation in The Netherlands. Infants were randomly assigned to six-month helmet therapy (Helmet Therapy, n = 42) or no helmet therapy (Natural Course, n = 42). Baseline measurements were performed at 5 months, follow-up measurements at 8, 12 and 24 months. Primary outcome was change in skull shape from 5 to 24 months assessed using plagiocephalometry (anthropometric measurement instrument). Furthermore, parental satisfaction (5-point Likert scale), side effects and motor development (BSID-III composite score) were assessed. Groups were compared using the independent t-test or chi square test. Change scores for plagiocephaly (Oblique Diameter Difference Index – ODDI) and brachycephaly (Cranio Proportional Index – CPI) were each included in an analysis of covariance (ANCOVA) using baseline values as covariate. Results The adjusted mean change scores from 5 to 24 months, were equal in both groups for plagiocephaly (ODDI: Natural Course: 2.6 (1.8 to 3.4); Helmet Therapy: 3.4 (2.6 to 4.2); p = 0.13) as well as brachycephaly (CPI Natural Course: 7.4 (6.4 to 8.5); Helmet Therapy: 6.4 (5.3 to 7.5); p = 0.20). The numbers of children showing full recovery were comparable in both groups (Natural Course: 9/40 (23%); Helmet Therapy: 10/39 (26%); p = 0.74). Parental Satisfaction was higher for parents of infants in the Helmet Therapy group (5 (4–5) than the Natural Course group (4 (4–5); p = 0.09). Motor development showed comparable scores (Natural Course 99.0 (11.6); Helmet Therapy 97.2 (9.4); p = 0.18). Almost all parents reported side effect of helmet therapy: acceptation problems (24%), skin irritation (96%), augmented sweating (71%) unpleasant smell of the helmet (76%) pain due to the helmet (33%) and feeling hindered to cuddle their baby (77%). Conclusion Based on the equal effectiveness of helmet therapy and natural course, a high prevalence of side effects and high costs of treatment, we discourage the use of a helmet as a standard treatment for healthy infants with moderate to severe skull deformation.

No abstract