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HElmet therapy Assessment in infants with Deformed Skulls (HEADS): protocol for a randomised controlled trial
Renske M van Wijk1, Magda M Boere-Boonekamp, Catharina G M Groothuis-Oudshoorn
1Department of Health Technology and Services Research, Institute for Governance Studies, University of Twente, Enschede, The Netherlands. r.m.vanwijk@utwente.nl
Insights
Helmet therapy for infant skull deformation lacks evidence. The HEADS study is a pragmatic RCT comparing helmet therapy to no helmet therapy to assess effectiveness and costs in infants with moderate to severe skull deformation.
Area of Science:
- Pediatric orthopedics
- Clinical trial methodology
- Infant health outcomes
Background:
- Helmet therapy is common for infant skull deformation in the Netherlands.
- Evidence for helmet therapy effectiveness is currently lacking.
- Deformational plagiocephaly and brachycephaly are common infant skull conditions.
Purpose of the Study:
- To determine the effects and costs of helmet therapy versus no helmet therapy.
- To assess helmet therapy's impact on head shape and infant well-being.
- To provide evidence for future treatment policies and reimbursement decisions.
Main Methods:
- Pragmatic randomized controlled trial (RCT) nested within a cohort study.
- Infants aged 2-4 months with skull deformation assessed; eligible infants at 5 months randomized.
- Follow-up at 8, 12, and 24 months, measuring head shape, parental satisfaction, infant development, and costs.
Main Results:
- This section is not available in the provided abstract.
- The study is designed to collect data on head shape at 24 months using plagiocephalometry.
- Secondary outcomes include parental satisfaction, infant development, and quality of life.
Conclusions:
- The HEADS study will be the first RCT to provide data on helmet therapy effectiveness.
- Findings will inform healthcare professionals, parents, and policy regarding infant helmet therapy.
- Results may influence reimbursement policies for health insurance companies.
Background:
In 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/Design:
Pragmatic 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.
Discussion:
HEADS 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 Registration:
ISRCTN18473161.
