Newborn Head Molding and Later Asymmetries

Study Overview
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Brief Summary
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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
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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.

Official Title
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Newborn Head Molding and Later Asymmetries in Follow up (3D Head Shape Modelling)

Conditions
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Plagiocephaly

Intervention / Treatment
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* Behavioral: Newborns with preventive caring advices
* Other: Newborns with normal caring advices


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: Congenital anomalies, Very early discharge, Parental refusal

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 6 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>Newborns with preventive caring advices | Behavioral: Newborns with preventive caring advices<br>* Advices to prevent head molding<br>|
| Placebo Comparator: Surveillance<br>Newborns with normal caring advices | Other: Newborns with normal caring advices<br>* Normal handling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Plagiocephaly (The number of children in groups with plagiocephaly (CI, OCLR =/> 104% ) | The number of children in groups with plagiocephaly (CI, OCLR =/> 104%) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of plagiocephaly | The number of children in groups with plagiocephaly as mild; aOCLR 104-107%; moderate 107-111%; severe =/>111 % | 3 months | 
| Change in plagiocephaly | The number of children in groups with plagiocephaly as mild; aOCLR 104-107%; moderate 107-111%; severe =/>111 % | From 3 to 6 months | 
| Occlusal defects | The number of children in groups with occlusal defects | 6 years | 
| Change in occlusal defects | The number of children with occlusal defects | from 6 years to 10 years | 
| Change in facial symmetry | The number of children with facial asymmetry | from 6 years to 10 years | 
| Change in occlusal defects | The number of children with occlusal defects | from 10 years to 15 years | 
| Change in facial symmetry | The number of children with facial asymmetry | from 10 years to 15 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plagiocephaly, torticollis, occlusal defect