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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25572

Enrollment

Registered

2010-06-28

Start date

2009-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

plagiocephaly, brachycephaly, skull deformation, helmet therapy, positional preference

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 mont

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children 5 months of age, either sex; 2. Moderate to severe DP: A. Plagiocephaly: 108% less than or equal to Oblique Diameter Difference Index (ODDI) less than or equal to 113%; B. Brachycephaly: 95% less than or equal to Cranial Proportional Index (CPI) less than or equal to 104%; C. 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
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) (AIMS, Van Wiechen, ASQ); 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) (STAI); 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) (AIMS, Van Wiechen, ASQ); 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) (STAI); 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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Contacts

Public ContactRenske M. Wijk, van

POBox 217

r.m.vanwijk@utwente.nl+31 (0)53 4894643

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)