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OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates

Study acronym: OPT-IN
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated August 3, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Re-verified, no change to tracked fieldsv5
  2. Minor Primary and study completion dates: Jul 2025 to Dec 2025v4
  3. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Enrollment target: 50 to 122
    • Primary endpoints: 2 to 3
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 2023 to Oct 26, 2023
  4. Minor Collaborators shortened, about 3 wordsv2
  5. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this crossover randomized clinical trial is to assess the effects of osteopathic manipulative treatment (OMT) compared to standard of care repositioning in children diagnosed with positional/deformational plagiocephaly. The main hypothesis is that children who received OMT will show significantly improved anthropometric measures of cranial symmetry over those receiving the current pediatric standard of care of repositioning. This is a two-arm, randomized cross-over clinical trial. With parental consent, pediatric patients (infants \<4 months of age) will be organized into one of two groups: 1. Those who receive OMT with emphasis on osteopathic cranial manipulative medicine (OCMM) to restore cranial symmetry. 2. Those who receive standard care only with repositioning attention from the parents After 8-weeks of being in the first group, each participant will cross-over into the second group (OMT or repositioning) N = 122 subjects diagnosed with deformational plagiocephaly (DP) are to be recruited (to allow for natural attrition and loss to follow up) with the recruitment to continue until 61 patients have been placed in each of the two groups and will cross-over to the respective treatment group (OMT and standard of care repositioning therapy). Timeline: It is projected that to recruit and carry out the assessments and interventions (8-weeks of each group with 12-months of follow-up longitudinally), it will require two years (24-months) from the beginning of the study to completion.
Trial Details
NCT Number NCT05848895
Lead Sponsor Osteopathy's Promise to Children
Conditions
(from sponsor)
Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional, Plagiocephaly, Cranium; Deformity
Related terms Congenital Abnormalities, Plagiocephaly, Plagiocephaly, Nonsynostotic
Enrollment 122 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov