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Newborn Head Molding and Later Asymmetries

StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv9
  2. Trial status: Active, Not Recruiting to Enrolling by Invitation
    • Primary completion date: Dec 2016 to Dec 2027
    • Study completion date: Feb 2024 to Dec 2027
    • Secondary endpoints: 4 to 7
    v8
  3. Publications: 4 to 6v7
  4. 2 versions Re-verified since May 1, 2017, no change to tracked fieldsv5-v6
  5. Primary completion date: Feb 2016 to Dec 2016v4 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 110 to confirmed 135
    • Site details revised
    • Publications expanded, about 150 words
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  1. Study Status, Referencesv3
  2. Primary endpoint revised
    • Secondary endpoints: 3 to 4
    • Study description expanded, about 8 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02283229
Lead Sponsor University of Oulu
Conditions
(from sponsor)		 Plagiocephaly
Related terms Plagiocephaly, Torticollis
Enrollment 135 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov