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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18473161

Enrollment

Registered

2008-10-17

Start date

2009-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 26, 2026