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

Completed

• Conditions: Deformational plagiocephaly/brachycephaly; Musculoskeletal Diseases; Congenital musculoskeletal deformities of head, face, spine and chest

• Registration Number: ISRCTN18473161
• Lead Sponsor: The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-17
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 96

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

Exclusion Criteria

1. Premature children
2. Children with congenital muscular torticollis
3. Synostosis
4. Dysmorphisms
5. Neurological dysfunctions

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(A)symmetry of the skull at 8, 12, and 24 months, measured by plagiocephalometry (PCM).

Secondary Outcome Measures

Name	Time	Method
Main study: <br>1. Subjective outcome score (at 5, 12, 24 months)<br>2. (Psycho)motor development (at 5, 12 and 24 months)<br>3. Quality of life (at 2 years)<br>4. Parental attitudes (at 5, 12 and 24 months)<br>5. Parental anxiety level and parental concerns (at 5, 12 and 24 months)<br>6. Satisfaction with the treatment (at 12 and 24 months)<br><br>Secondary outcome of the ancillary methods study:<br>1. Decisional conflict scale<br>2. Actual preference for treatment (helmet, wait-and-see, randomised controlled trial [RCT])<br>3. Stated preference for treatment