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Newborn Head Molding and Later Asymmetries
Sponsor: University of Oulu
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.
Official title: Newborn Head Molding and Later Asymmetries in Follow up (3D Head Shape Modelling)
Key Details
Gender
All
Age Range
1 Day - 6 Days
Study Type
INTERVENTIONAL
Enrollment
135
Start Date
2012-02
Completion Date
2027-12
Last Updated
2023-11-28
Healthy Volunteers
Yes
Conditions
Interventions
Newborns with preventive caring advices
Advices to prevent head molding
Newborns with normal caring advices
Normal handling
Locations (1)
Oulu University Hospital
Oulu, Finland