Newborn Head Molding and Later Asymmetries
- Conditions
- Plagiocephaly
- Interventions
- Behavioral: Newborns with preventive caring advicesOther: Newborns with normal caring advices
- Registration Number
- NCT02283229
- Lead Sponsor
- University of Oulu
- 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 Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 135
- 1-6 days after birth;
- Healthy newborns in maternal ward, and living in near by Oulu region.
- Preterms at the age of 34-44 gestation weeks in near by Oulu region (non randomized)
- Congenital anomalies,
- Very early discharge,
- Parental refusal
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Newborns with preventive caring advices Newborns with preventive caring advices Surveillance Newborns with normal caring advices Newborns with normal caring advices
- Primary Outcome Measures
Name Time Method Presence of Plagiocephaly (The number of children in groups with plagiocephaly (CI, OCLR =/> 104% ) 3 months The number of children in groups with plagiocephaly (CI, OCLR =/\> 104%)
- Secondary Outcome Measures
Name Time Method Severity of plagiocephaly 3 months The number of children in groups with plagiocephaly as mild; aOCLR 104-107%; moderate 107-111%; severe =/\>111 %
Change in occlusal defects from 10 years to 15 years The number of children with occlusal defects
Change in facial symmetry from 10 years to 15 years The number of children with facial asymmetry
Change in plagiocephaly 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 6 years The number of children in groups with occlusal defects
Trial Locations
- Locations (1)
Oulu University Hospital
🇫🇮Oulu, Finland