Contact information
Type
Scientific
Primary contact
Dr Magda M. Boere-Boonekamp
ORCID ID
Contact details
University of Twente
Health Technology and Services Research
Drienerlolaan 5
P.O.Box 217
Enschede
7500 AE
Netherlands
+31 (0)53 4894483
M.M.Boere-Boonekamp@utwente.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ZonMw nr 170992501
Study information
Scientific title
Acronym
Study hypothesis
In comparison with a wait-and-see regimen, redression helmet treatment in infants with deformational plagiocephaly (DP) is more effective, measured subjectively with a Satisfaction Outcome Score and objectively with plagiocephalometry.
An ancilliary study is also taking place with the following objective: what is the agreement between parental stated preferences for management of plagiocephaly (measured with conjoint analysis) and actual management preferences (helmet treatment, randomisation, wait and see)?
Thw hypothesis for this ancilliary study is that parental stated preferences predict parental actual decision making.
As of 31/01/2012, the anticipated end date of trial was updated from 31/12/2011 to 30/04/2013.
Ethics approval
Added 11/03/2009: Medical Ethics Committee gave approval on the 8th January 2009 (ref: NL24352.044.08)
Study design
Randomised controlled trial, nested in a follow-up study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Deformational plagiocephaly/brachycephaly
Intervention
Included children will be randomly assigned to either helmet treatment or a wait-and-see regimen, both for a period of 6 months.
Intervention group:
Helmet treatment initiated at the age of 5 months and supervised by a physician in one of the two specialised centres. A custom-made helmet is constructed by an orthotist and is made of mouldable plastic. The helmet is worn both day and night, for an average of four to six months.
Wait-and-see group:
Recovery of the deformation of the head is awaited by allowing spontaneous growth of the skull. Preceding physiotherapy will be discontinued.
The paediatric physiotherapist will perform the follow-up measurements in both the intervention and the wait-and-see group at the age of 8, 12, and 24 months (and 48 months, beyond the scope of this study). During these measuring moments, advice is given on positioning and handling of the child. This advice is also given by YHC physicians and nurses as part of usual care to all infants.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
(A)symmetry of the skull at 8, 12, and 24 months, measured by plagiocephalometry (PCM).
Secondary outcome measures
Main study:
1. Subjective outcome score (at 5, 12, 24 months)
2. (Psycho)motor development (at 5, 12 and 24 months)
3. Quality of life (at 2 years)
4. Parental attitudes (at 5, 12 and 24 months)
5. Parental anxiety level and parental concerns (at 5, 12 and 24 months)
6. Satisfaction with the treatment (at 12 and 24 months)
Secondary outcome of the ancillary methods study:
1. Decisional conflict scale
2. Actual preference for treatment (helmet, wait-and-see, randomised controlled trial [RCT])
3. Stated preference for treatment
Overall trial start date
01/01/2009
Overall trial end date
30/04/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children 5 months of age, either sex
2. Moderate to severe DP:
2.1. Plagiocephaly: 108% less than or equal to Oblique Diameter Difference Index (ODDI) less than or equal to 113%
2.2. Brachycephaly: 95% less than or equal to Cranial Proportional Index (CPI) less than or equal to 104%
2.3. Mixed forms according to adjusted criteria
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
96
Participant exclusion criteria
1. Premature children
2. Children with congenital muscular torticollis
3. Synostosis
4. Dysmorphisms
5. Neurological dysfunctions
Recruitment start date
01/01/2009
Recruitment end date
30/04/2013
Locations
Countries of recruitment
Netherlands
Trial participating centre
University of Twente
Enschede
7500 AE
Netherlands
Sponsor information
Organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Sponsor details
Laan van Nieuw Oost Indië 334
P.O.Box 93245
The Hague
2509 AE
Netherlands
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 80-82310-98-09091)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22776627
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24784879
Publication citations
-
Protocol
van Wijk RM, Boere-Boonekamp MM, Groothuis-Oudshoorn CG, van Vlimmeren LA, IJzerman MJ, HElmet therapy Assessment in infants with Deformed Skulls (HEADS): protocol for a randomised controlled trial., Trials, 2012, 13, 108, doi: 10.1186/1745-6215-13-108.
-
Results
van Wijk RM, van Vlimmeren LA, Groothuis-Oudshoorn CG, Van der Ploeg CP, Ijzerman MJ, Boere-Boonekamp MM, Helmet therapy in infants with positional skull deformation: randomised controlled trial., BMJ, 2014, 348, g2741.