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Enrolling by Invitation

NCT Number: NCT02283229

Newborn Head Molding and Later Asymmetries

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Newborns with preventive caring advices

Behavioral

Advices to prevent head molding

Newborns with normal caring advices

Other

Normal handling

Primary outcomes

  1. 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%)

Secondary outcomes

  1. 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 %

  2. 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 %

  3. Occlusal defects

    Time frame: 6 years

    The number of children in groups with occlusal defects

  4. Change in occlusal defects

    Time frame: from 6 years to 10 years

    The number of children with occlusal defects

  5. Change in facial symmetry

    Time frame: from 6 years to 10 years

    The number of children with facial asymmetry

  6. Change in occlusal defects

    Time frame: from 10 years to 15 years

    The number of children with occlusal defects

  7. Change in facial symmetry

    Time frame: from 10 years to 15 years

    The number of children with facial asymmetry

Other outcomes

  1. Development (Development quotients by Griffiths scales in groups)

    Time frame: 3 months

    Difference in Development quotients by Griffiths scales in groups

  2. Change in Development (Development quotients by Griffiths scales in groups)

    Time frame: From 3 months to 6 months

    Difference in Development quotients by Griffiths scales in groups

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2027
Study completion
2027
First posted
Nov 5, 2014
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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