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

In The Netherlands helmet therapy is a commonly used treatment in infants with skull deformation (deformational plagiocephaly or deformational brachycephaly). However, evidence on the effectiveness of this treatment is 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. Pragmatic randomized controlled trial (RCT) nested in a cohort study. The cohort study includes infants with a positional preference and/or skull deformation at two to four months (first assessment). At 5 months of age, all children will be assessed again and infants meeting criteria for helmet therapy will be asked to participate in the RCT. Participants will be randomly allocated to either helmet therapy or no helmet therapy. Parents of eligible infants that do not agree with enrollment in the RCT are invited to stay enrolled for follow up in a non-randomized controlled trial (nRCT); they will make the decision to start helmet therapy or not themselves. Assessments will take place at 8, 12 and 24 months of age. Main outcome is head shape measured with plagiocephalometry. Secondary outcomes are parental satisfaction with the condition, concerns about the future, anxiety level and satisfaction with the treatment and motor development and quality of life of the infant. Finally compliance and costs will also be determined. HEADS will be the first study to present data on the effectiveness of helmet therapy. Outcomes will be important for parents and their children, health care professionals and future treatment policies. They will likely influence the reimbursement of health insurance companies. Besides these health outcomes we will be able to answer several methodological questions, e.g. do participants in a RCT represent the eligible target population and do outcomes of the RCT differ from outcomes found in the nRCT? Trial registration - ISRCTN18473161