OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates

Plagiocephaly Clinical Trial

— OPT-IN  

Official title:

OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05848895
• Other study ID #: OPC001
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2023
• Est. completion date: July 2025

Study information

• Verified date: October 2023
• Source: Osteopathy's Promise to Children
• Contact: Kimberly J Wolf, DO
• Phone: 19373699290
• Email: wolfkimb[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 4 Months

Eligibility

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

Related Conditions & MeSH terms

• Plagiocephaly
• Plagiocephaly, Nonsynostotic
• Plagiocephaly, Positional

Intervention

Procedure:
• Osteopathic Manipulative Treatment
Osteopathic Manipulative Treatment is a manual treatment therapy applied by licensed physicians that consists of using ones hands to improve the structure and function of the body. In this situation it will involve gentle and passive modalities that are well-tolerated by infants.

Behavioral:
• Standard of Care Repositioning
Parents will receive standardized handouts/materials instructing on repositioning intended to help improve head shape in infants with plagiocephaly.

Locations

Country	Name	City	State
United States	Osteopathic Center San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Osteopathy's Promise to Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cranial Vault Asymmetry Index	Anthropometric measurement of cranial asymmetry	2 years
Primary	Head circumference	Standard growth parameter measured in infants	2 years
Primary	Weight	Standard growth parameter measured in infants	2 years
Secondary	Medical history	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.	12 months
Secondary	Developmental Milestones	Patients' enrolled in the study will have developmental stones monitored as per general pediatrician's protocol to screen for developmental delays.	12 months