Clinical Trial: Newborn Head Molding and Later Asymmetries

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.


Detailed Summary:

The amount of craniofacial abnormal molding after birth in newborns and the frequency of plagiocephaly in infancy or later consequences of those in childhood are not known in finnish population. Head malposition and deformational plagiocephaly, however, have been linked to delayed development in early life and even much later to orthognathic problems demanding surgery in adulthood.

In this study parents with healthy newborns are randomized to have normal discharge home or discharged with extra advice information for caregivers; to charge both sided feeding and handling habits; to change regularly sleeping and lying positions; to have early tummy times.

Anthropometric measurements of the infants; tilting degrees of the head and rotations of the neck (range of movement =ROM) are taken at discharge home and at the age of 3 and 6 months, and 1, 3, 5-6 and 8-9 years. Two-dimensional digital photographs (upto the age of 6 months) and three-dimensional imaging (from the age of 3 months) are taken to measurements of the head shape (Cephalic index=CI and (approximate) Oblique Cranial Length Ratio= (a)OCLR measured using a semiautomated, computer-based method). The development quotient by Griffiths scales are assessed at the age of 3 and 6 months. Dental occlusal defect evaluation are started at the age of 3 ys.


Sponsor: University of Oulu

Current Primary Outcome: Presence of Plagiocephaly (The number of children in groups with plagiocephaly (CI, OCLR =/> 104% ) [ Time Frame: 3 months ]

The number of children in groups with plagiocephaly (CI, OCLR =/> 104%)


Original Primary Outcome: Plagiocephaly (The number of children in groups with plagiocephaly (CI, TDD > 105 or <95 or/and ROM > 15) [ Time Frame: 3 months ]

The number of children in groups with plagiocephaly (CI, TDD > 105 or <95 or/and ROM > 15)


Current Secondary Outcome:

  • Severity of plagiocephaly [ Time Frame: 3 months ]
    The number of children in groups with plagiocephaly as mild; aOCLR 104-107%; moderate 107-111%; severe =/>111 %
  • Change in plagiocephaly [ Time Frame: From 3 to 6 months ]
    The number of children in groups with plagiocephaly as mild; aOCLR 104-107%; moderate 107-111%; severe =/>111 %
  • Occlusal defects (The number of children in groups with occlusal defects) [ Time Frame: 6 years ]
    The number of children in groups with occlusal defects
  • Change in occlusal defects [ Time Frame: from 6 years to 9 years ]
    The number of children in groups with occlusal defects


Original Secondary Outcome:

  • Change in plagiocephaly [ Time Frame: 6 months ]
    The number of children in groups with plagiocephaly (CI, TDD > 105 or <95 or/and ROM > 15)
  • Occlusal defects (The number of children in groups with occlusal defects) [ Time Frame: 6 years ]
    The number of children in groups with occlusal defects
  • Change in occlusal defects [ Time Frame: from 6 years to 9 years ]
    The number of children in groups with occlusal defects


Information By: University of Oulu

Dates:
Date Received: October 28, 2014
Date Started: February 2012
Date Completion: February 2024
Last Updated: May 1, 2017
Last Verified: May 2017