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Newborn Head Molding and Later Asymmetries

NCT02283229 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2023-11-28

No results posted yet for this study

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.

Conditions

  • Plagiocephaly

Interventions

BEHAVIORAL

Newborns with preventive caring advices

Advices to prevent head molding

OTHER

Newborns with normal caring advices

Normal handling

Sponsors & Collaborators

  • University of Oulu

    lead OTHER

Principal Investigators

  • Pertti Pirttiniemi, Professor · University of Oulu

  • Marita Valkama, Ph.D., M.D. · University of Oulu, Oulu University Hospital

  • Virpi Harila, Ph.D. · University of Oulu

  • Henri Aarnivala, M.D. · University of Oulu

  • Tuomo Heikkinen, Dos · University of Oulu

  • Ville Vuollo, Ph.M. · University of Oulu

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
6 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02283229 on ClinicalTrials.gov