HElmet therapy Assessment in infants with Deformed Skulls (HEADS): protocol for a randomised controlled trial

Renske M. van Wijk*, Magda M. Boere-Boonekamp, Catharina G.M. Groothuis-Oudshoorn, Leo A. van Vlimmeren, Maarten J. IJzerman

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

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.

Original languageEnglish
Article number108
JournalTrials
Volume13
DOIs
Publication statusPublished - 9 Jul 2012
Externally publishedYes

Bibliographical note

Funding Information:
We thank all HEADS paediatric physical therapists for recruiting and following participants of the HEADS study and H. Wierenga MD, PhD, for being an independent advisor to parents. Furthermore, we would like to thank the (paediatric) physicians and orthotists working at the various institutions providing helmet therapy, for willingness to co-operate with the HEADS study. Finally, we also thank the HEADS project group, HEADS project group advisors, TNO Quality of Life and the Royal Dutch Society for Physical Therapy for their collaboration. This study was funded by ZonMw, the Netherlands Organization for Health Research and Development (grant number 170.992.501). Besides the initial review process before funding and amendments, ZonMw did not have any involvement in the design and management of the study and publications concerning HEADS.

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