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OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates (OPT-IN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05848895
Recruitment Status : Recruiting
First Posted : May 8, 2023
Last Update Posted : November 1, 2023
Sponsor:
Information provided by (Responsible Party):
Kimberly Wolf, 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.


Condition or disease Intervention/treatment Phase
Plagiocephaly, Nonsynostotic Plagiocephaly, Positional Plagiocephaly Cranium; Deformity Procedure: Osteopathic Manipulative Treatment Behavioral: Standard of Care Repositioning Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates
Actual Study Start Date : October 26, 2023
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Osteopathic Manipulative Treatment
Patients will be treated once a week with OMT x 8 weeks
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.

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




Primary Outcome Measures :
  1. Cranial Vault Asymmetry Index [ Time Frame: 2 years ]
    Anthropometric measurement of cranial asymmetry

  2. Head circumference [ Time Frame: 2 years ]
    Standard growth parameter measured in infants

  3. Weight [ Time Frame: 2 years ]
    Standard growth parameter measured in infants


Secondary Outcome Measures :
  1. Medical history [ Time Frame: 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.

  2. Developmental Milestones [ Time Frame: 12 months ]
    Patients' enrolled in the study will have developmental stones monitored as per general pediatrician's protocol to screen for developmental delays.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Day to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05848895


Contacts
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Contact: Kimberly J Wolf, DO 19373699290 wolfkimb@gmail.com
Contact: Jessica Martone, PhD, MSW 619-693-6303 jessica.martone@the-promise.org

Locations
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United States, California
Osteopathic Center San Diego Recruiting
San Diego, California, United States, 92123
Contact: Jessica Martone, PhD, MSW    619-693-6303    jessica.martone@the-promise.org   
Contact: Kimberly Wolf, DO    619-693-6303    kimberly.wolf@the-promise.org   
Principal Investigator: Kimberly Wolf, DO         
Sponsors and Collaborators
Osteopathy's Promise to Children
Investigators
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Principal Investigator: Kimberly J Wolf, DO Osteopathy's Promise to Children
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Responsible Party: Kimberly Wolf, Kimberly Wolf, DO, Osteopathy's Promise to Children
ClinicalTrials.gov Identifier: NCT05848895    
Other Study ID Numbers: OPC001
First Posted: May 8, 2023    Key Record Dates
Last Update Posted: November 1, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kimberly Wolf, Osteopathy's Promise to Children:
Positional Plagiocephaly
Nonsynostotic Plagiocephaly
Repositioning
Osteopathic Manipulative Treatment
Cranial asymetry
Additional relevant MeSH terms:
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Plagiocephaly
Plagiocephaly, Nonsynostotic
Congenital Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases