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OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates

RecruitingNAAges 1 Day - 4 MonthsAllOsteopathy's Promise to Children
NCT05848895 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 t

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📋 Eligibility rules (as published)
Inclusions: * Diagnosed with positional plagiocephaly * Under 4-months of age (between birth - 4 months) at the time of enrollment Exclusions: * Preterm birth (\<37 weeks) * Genetic syndromes * Craniofacial defects/deformities (e.g. cleft lip/palate) * Brachycephaly/scaphocephaly * Hypotonia * Hypertonia * Craniosynostosis * Head trauma or other neurological illnesses * Lost to follow up * Patient whose parents (or legal guardians) disagree to attend 8-treatments of OMT and 2 additional measurement sessions * Prior helmet therapy, physical therapy, or OMT before the date of enrollment
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What it tests

  • Osteopathic Manipulative Treatment
  • Standard of Care Repositioning
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Where

1 site
Osteopathic Center San Diego
San Diego, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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