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ENROLLING BY INVITATION
NCT02283229
NA

Newborn Head Molding and Later Asymmetries

Sponsor: University of Oulu

View on ClinicalTrials.gov

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

BEHAVIORAL

Newborns with preventive caring advices

Advices to prevent head molding

OTHER

Newborns with normal caring advices

Normal handling

Locations (1)

Oulu University Hospital

Oulu, Finland