Plagiocephaly
Conditions
Keywords
Plagiocephaly, torticollis, occlusal defect
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.
Interventions
BEHAVIORALNewborns with preventive caring advices
Advices to prevent head molding
OTHERNewborns with normal caring advices
Normal handling
Sponsors
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Days to 6 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| Change in occlusal defects | from 6 years to 10 years | The number of children with occlusal defects |
| Change in facial symmetry | from 6 years to 10 years | The number of children with facial asymmetry |
Other
| Measure | Time frame | Description |
|---|---|---|
| Development (Development quotients by Griffiths scales in groups) | 3 months | Difference in Development quotients by Griffiths scales in groups |
| Change in Development (Development quotients by Griffiths scales in groups) | From 3 months to 6 months | Difference in Development quotients by Griffiths scales in groups |
Countries
Finland
Outcome results
None listed