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Newborn Head Molding and Later Asymmetries

NCT ID: NCT02283229

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2027-12-31

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.

Conditions

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Plagiocephaly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Active

Newborns with preventive caring advices

Group Type ACTIVE_COMPARATOR

Newborns with preventive caring advices

Intervention Type BEHAVIORAL

Advices to prevent head molding

Surveillance

Newborns with normal caring advices

Group Type PLACEBO_COMPARATOR

Newborns with normal caring advices

Intervention Type OTHER

Normal handling

Interventions

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Newborns with preventive caring advices

Advices to prevent head molding

Intervention Type BEHAVIORAL

Newborns with normal caring advices

Normal handling

Intervention Type OTHER

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
Minimum Eligible Age

1 Day

Maximum Eligible Age

6 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Marita Valkama

PhD, M.D. Adjunct Professor, pediatrician and neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pertti Pirttiniemi, Professor

Role: STUDY_CHAIR

University of Oulu

Marita Valkama, Ph.D., M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Oulu, Oulu University Hospital

Virpi Harila, Ph.D.

Role: STUDY_DIRECTOR

University of Oulu

Henri Aarnivala, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Oulu

Tuomo Heikkinen, Dos

Role: PRINCIPAL_INVESTIGATOR

University of Oulu

Ville Vuollo, Ph.M.

Role: PRINCIPAL_INVESTIGATOR

University of Oulu

Locations

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Oulu University Hospital

Oulu, , Finland

Site Status

Countries

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Finland

References

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Aarnivala HE, Valkama AM, Pirttiniemi PM. Cranial shape, size and cervical motion in normal newborns. Early Hum Dev. 2014 Aug;90(8):425-30. doi: 10.1016/j.earlhumdev.2014.05.007. Epub 2014 Jun 13.

Reference Type RESULT
PMID: 24951081 (View on PubMed)

Aarnivala H, Vuollo V, Harila V, Heikkinen T, Pirttiniemi P, Valkama AM. Preventing deformational plagiocephaly through parent guidance: a randomized, controlled trial. Eur J Pediatr. 2015 Sep;174(9):1197-208. doi: 10.1007/s00431-015-2520-x. Epub 2015 Apr 1.

Reference Type RESULT
PMID: 25823758 (View on PubMed)

Vuollo V, Holmstrom L, Aarnivala H, Harila V, Heikkinen T, Pirttiniemi P, Valkama AM. Analyzing infant head flatness and asymmetry using kernel density estimation of directional surface data from a craniofacial 3D model. Stat Med. 2016 Nov 20;35(26):4891-4904. doi: 10.1002/sim.7032. Epub 2016 Jul 6.

Reference Type RESULT
PMID: 27383684 (View on PubMed)

Aarnivala H, Vuollo V, Harila V, Heikkinen T, Pirttiniemi P, Holmstrom L, Valkama AM. The course of positional cranial deformation from 3 to 12 months of age and associated risk factors: a follow-up with 3D imaging. Eur J Pediatr. 2016 Dec;175(12):1893-1903. doi: 10.1007/s00431-016-2773-z. Epub 2016 Sep 13.

Reference Type RESULT
PMID: 27624627 (View on PubMed)

Launonen AM, Vuollo V, Aarnivala H, Heikkinen T, Pirttiniemi P, Valkama AM, Harila V. Craniofacial Asymmetry from One to Three Years of Age: A Prospective Cohort Study with 3D Imaging. J Clin Med. 2019 Dec 27;9(1):70. doi: 10.3390/jcm9010070.

Reference Type RESULT
PMID: 31892114 (View on PubMed)

Launonen AM, Aarnivala H, Kyteas P, Vuollo V, Heikkinen T, Kau CH, Pirttiniemi P, Harila V, Valkama AM. A 3D Follow-Up Study of Cranial Asymmetry from Early Infancy to Toddler Age after Preterm versus Term Birth. J Clin Med. 2019 Oct 11;8(10):1665. doi: 10.3390/jcm8101665.

Reference Type RESULT
PMID: 31614700 (View on PubMed)

Other Identifiers

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EETTMK:27/2011

Identifier Type: -

Identifier Source: org_study_id