Newborn Head Molding and Later Asymmetries

University of Oulu

Status: Invitation-only

Conditions: Plagiocephaly

Treatments: Behavioral: Newborns with preventive caring advices; Other: Newborns with normal caring advices

Study type: Interventional

Funder types: Other

Identifiers

NCT02283229

EETTMK:27/2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 estimated patients

Sex: All

Ages: 1 to 6 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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135 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Description:

Newborns with preventive caring advices

Treatment:

Behavioral: Newborns with preventive caring advices

Surveillance

Placebo Comparator group

Description:

Newborns with normal caring advices

Treatment:

Other: Newborns with normal caring advices