Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Newborn Head Molding and Later Asymmetries in Follow up (3D Head Shape Modelling)
Brief 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.