Clinical trial NCT05848895: OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates
Official title: OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Plagiocephaly, Nonsynostotic
Plagiocephaly, Positional
Plagiocephaly
Cranium; Deformity
Keywords: Positional Plagiocephaly
Nonsynostotic Plagiocephaly
Repositioning
Osteopathic Manipulative Treatment
Cranial asymetry
Lead sponsor: Osteopathy's Promise to Children
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 122
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cranial Vault Asymmetry Index
timeFrame: 2 years
measure: Head circumference
timeFrame: 2 years
measure: Weight
timeFrame: 2 years
Secondary outcomes:
measure: Medical history
timeFrame: 12 months
measure: Developmental Milestones
timeFrame: 12 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Osteopathic Center San Diego
state: California
Study officials:
affiliation: Osteopathy's Promise to Children
name: Kimberly J Wolf, DO
role: PRINCIPAL_INVESTIGATOR
References: