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

Completed

• Conditions: head molding; plagiocephaly; 10005959

• Registration Number: NL-OMON35689
• Lead Sponsor: niversiteit Twente

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 96

Inclusion Criteria

Infants in the age of 5-6 months with the following PCM inclusion criteria: plagiocephaly 108% <= ODDI <= 113, brachycephaly 95 <= CPI <= 104%, mixed forms according to adjusted criteria for ODDI and CPI.

Exclusion Criteria

Premature children (< 37 weeks), children with congenital muscular torticollis, synostotic plagiocephaly and/or dysmorphisms

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is the (a)symmetry of the skull at 8, 12, and 24 months,<br /><br>measured<br /><br>by PCM.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome of the main study:<br /><br>- subjective outcome score;<br /><br>- (psycho)motor development;<br /><br>- quality of life;<br /><br>- parental attitudes;<br /><br>- parental anxiety level and parental concerns;<br /><br>- satisfaction with the treatment.<br /><br><br /><br>Secondary outcome of the ancillary methods study:<br /><br>- actual preference for treatment (randomisation, helmet, wait-and-see);<br /><br>- Decisional Conflict Scale;<br /><br>- stated preference for treatment.</p><br>