Deformational plagiocephaly: effects and costs of helmet treatment and a wait-and-see regimen
| ISRCTN | ISRCTN18473161 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18473161 |
| Secondary identifying numbers | ZonMw nr 170992501 |
- 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
Scientific
University of Twente
Health Technology and Services Research
Drienerlolaan 5
P.O.Box 217
Enschede
7500 AE
Netherlands
| Phone | +31 (0)53 4894483 |
|---|---|
| M.M.Boere-Boonekamp@utwente.nl |
Study information
| Study design | Randomised controlled trial, nested in a follow-up study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | (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 study start date | 01/01/2009 |
| Completion date | 30/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Months |
| Sex | Both |
| Target number of participants | 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
7500 AE
Netherlands
Sponsor information
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Research organisation
Research organisation
Laan van Nieuw Oost Indië 334
P.O.Box 93245
The Hague
2509 AE
Netherlands
| Website | http://www.zonmw.nl |
|---|---|
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 80-82310-98-09091)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 09/07/2012 | Yes | No | |
| Results article | results | 01/05/2014 | Yes | No |
