Trial reportTrials2012
HElmet therapy Assessment in infants with Deformed Skulls (HEADS): protocol for a randomised controlled trial.
Trial report in Trials, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02370901 (Cranial Orthotic Device Versus Repositioning Techniques for the Management of Plagiocephaly), which is not on this map. Cited by 8 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Cranial Orthotic Device Versus Repositioning Techniques for the Management of Plagiocephaly: the CRANIO Randomized Trial
Who cites it
8 citing papers in PubMed.
- Efficacy of pediatric integrative manual therapy in positional plagiocephaly: a randomized controlled trial.Italian journal of pediatrics · 2021Trial
- Helmet therapy in infants with positional skull deformation: randomised controlled trial.BMJ (Clinical research ed.) · 2014Trial
- Effectiveness of Helmet therapy for infants with moderate to severe positional plagiocephaly.Clinical and experimental pediatrics · 2024Article
- Natural-Course Evaluation of Infants with Positional Severe Plagiocephaly Using a Three-Dimensional Scanner in Japan: Comparison with Those Who Received Cranial Helmet Therapy.Journal of clinical medicine · 2021Article
- Significant Factors in Cranial Remolding Orthotic Treatment of Asymmetrical Brachycephaly.Journal of clinical medicine · 2020Article
- Insufficient vitamin D supplement use during pregnancy and early childhood: a risk factor for positional skull deformation.Maternal & child nutrition · 2016Observational
- Parents' decision for helmet therapy in infants with skull deformation.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2014Article
- Effects of adherence to treatment for repositioning therapy, physical therapy, and cranial remolding orthoses in infants with cranial deformation.Journal of rehabilitation and assistive technologies engineeringArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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. 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 registrationISRCTN18473161.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.