OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates

Not Applicable

Recruiting

• Conditions: Cranium; Deformity; Plagiocephaly, Positional; Plagiocephaly; Plagiocephaly, Nonsynostotic
• Interventions: Procedure: Osteopathic Manipulative Treatment; Behavioral: Standard of Care Repositioning

• Registration Number: NCT05848895
• Lead Sponsor: Osteopathy's Promise to Children

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-28
• Study First Submitted QC: 2023-04-28
• Study First Posted: 2023-05-08
• Study Start: 2023-10-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Osteopathic Manipulative Treatment	Osteopathic Manipulative Treatment	Patients will be treated once a week with OMT x 8 weeks
Standard of Care Repositioning	Standard of Care Repositioning	Patients will only receive repositioning only x 8 weeks and all parents will receive standardized materials to counsel/instruct on the repositioning

Primary Outcome Measures

Name	Time	Method
Weight	2 years	Standard growth parameter measured in infants
Head circumference	2 years	Standard growth parameter measured in infants
Cranial Vault Asymmetry Index	2 years	Anthropometric measurement of cranial asymmetry

Secondary Outcome Measures

Name	Time	Method
Developmental Milestones	12 months	Patients' enrolled in the study will have developmental stones monitored as per general pediatrician's protocol to screen for developmental delays.
Medical history	12 months	Patients charts will be reviewed after first year of life to assess for medical issues including otitis media, developmental delay, allergic rhinitis, vision problems, torticollis, hospitalizations, need for a helmet to treat plagiocephaly, colic, reflux/GER, etc.

Trial Locations

Locations (1)

Osteopathic Center San Diego; 🇺🇸 San Diego, California, United States