Deformational plagiocephaly: effects and costs of helmet treatment and a wait-and-see regimen

ISRCTN	ISRCTN18473161
DOI	https://doi.org/10.1186/ISRCTN18473161
Protocol serial number	ZonMw nr 170992501
Sponsor	The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 80-82310-98-09091)

Submission date: 19/09/2008
Registration date: 17/10/2008
Last edited: 19/06/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Magda M. Boere-Boonekamp
Scientific

University of Twente
Health Technology and Services Research
Drienerlolaan 5
P.O.Box 217
Enschede
7500 AE
Netherlands

Phone	+31 (0)53 4894483
Email	M.M.Boere-Boonekamp@utwente.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial, nested in a follow-up study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	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(s)	Added 11/03/2009: Medical Ethics Committee gave approval on the 8th January 2009 (ref: NL24352.044.08)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	(A)symmetry of the skull at 8, 12, and 24 months, measured by plagiocephalometry (PCM).
Key secondary outcome measure(s)	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
Completion date	30/04/2013

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	5 Months
Sex	All
Target sample size at registration	96
Key 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
Key exclusion criteria	1. Premature children 2. Children with congenital muscular torticollis 3. Synostosis 4. Dysmorphisms 5. Neurological dysfunctions
Date of first enrolment	01/01/2009
Date of final enrolment	30/04/2013

Locations

Countries of recruitment

Netherlands

Study participating centre

University of Twente

Enschede
7500 AE
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2014		Yes	No
Protocol article	protocol	09/07/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes