Clinical Trial

Newborn Head Molding and Later Asymmetries

Enrolling by Invitation
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Summary
Prospective randomized clinical interventional trial after birth in maternity ward, and follow up to 8-9 years of age. Hypothesis: Preventive handling and caring advices to parents of newborns decrease craniofacial asymmetries (deformational plagiocephaly and torticollis). The minimum sample size of the study was calculated at 86 (43 in each arm) using a 5% significance level, a power of 80% and a fall in the prevalence of DP from 31% to 8%. Craniofacial asymmetries and appearances of occlusal defects are followed up to 9 years. 50 preterm infants can participate without intervention.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2014-11-02; most recent amendment 2023-11-27.
Status change: Active, Not Recruiting → Enrolling by Invitation 2022-06-14
Status change: Recruiting → Active, Not Recruiting 2016-11-02
Trial Details
NCT Number NCT02283229
Lead Sponsor University of Oulu
Conditions Plagiocephaly
Enrollment 135 participants
Start Date 2012-02
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2023-11-28