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Helmet therapy in infants with positional skull deformation: randomised controlled trial
Renske M van Wijk1, Leo A van Vlimmeren, Catharina G M Groothuis-Oudshoorn
1Department Health Technology and Services Research, Institute of Innovation and Governance Studies, University of Twente, Drienerlolaan 5, 7522 NB, Enschede, Netherlands.
BMJ (Clinical Research Ed.)
|May 3, 2014
Summary
Helmet therapy showed no significant benefit for positional skull deformation in infants compared to natural healing. The study found similar outcomes and a high prevalence of side effects with helmet use.
Area of Science:
- Pediatric Medicine
- Craniofacial Development
- Clinical Trials
Background:
- Positional skull deformation is a common condition in infants.
- Helmet therapy is a frequently used intervention, but its effectiveness compared to natural resolution is debated.
Purpose of the Study:
- To evaluate the efficacy of helmet therapy versus natural course for moderate to severe positional skull deformation in 5-6 month old infants.
- To compare outcomes including skull shape, facial symmetry, and motor development.
Main Methods:
- A pragmatic, single-blinded, randomized controlled trial (HEADS study) involving 84 infants aged 5-6 months.
- Infants were randomized to receive 6 months of helmet therapy or the natural course of the condition.
- Primary outcome was change in skull shape assessed via plagiocephalometry at 24 months.
Main Results:
- No significant difference in skull shape improvement (plagiocephaly and brachycephaly) between helmet therapy and natural course groups.
- Full recovery rates were similar: 26% with helmets versus 23% without.
- All parents reported side effects associated with helmet use.
Conclusions:
- Helmet therapy is not more effective than natural resolution for moderate to severe positional skull deformation in infants.
- Discourages routine helmet use due to lack of efficacy, side effects, and cost.
- Highlights the importance of considering conservative management for this condition.
