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

Primary Purpose

Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional, Plagiocephaly

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Osteopathic Manipulative Treatment
Standard of Care Repositioning
Sponsored by
Osteopathy's Promise to Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plagiocephaly, Nonsynostotic focused on measuring Positional Plagiocephaly, Nonsynostotic Plagiocephaly, Repositioning, Osteopathic Manipulative Treatment, Cranial asymetry

Eligibility Criteria

1 Day - 4 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Osteopathic Manipulative Treatment

    Standard of Care Repositioning

    Arm Description

    Patients will be treated once a week with OMT x 8 weeks

    Patients will only receive repositioning only x 8 weeks and all parents will receive standardized materials to counsel/instruct on the repositioning

    Outcomes

    Primary Outcome Measures

    Cranial Vault Asymmetry Index
    Anthropometric measurement of cranial asymmetry
    Head circumference
    Standard growth parameter measured in infants

    Secondary Outcome Measures

    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.
    Developmental Milestones
    Patients' enrolled in the study will have developmental stones monitored as per general pediatrician's protocol to screen for developmental delays.

    Full Information

    First Posted
    April 28, 2023
    Last Updated
    May 8, 2023
    Sponsor
    Osteopathy's Promise to Children
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05848895
    Brief Title
    OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates
    Acronym
    OPT-IN
    Official Title
    OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    July 2025 (Anticipated)
    Study Completion Date
    July 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Osteopathy's Promise to Children

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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: Those who receive OMT with emphasis on osteopathic cranial manipulative medicine (OCMM) to restore cranial symmetry. 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 = 50 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 25 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional, Plagiocephaly, Cranium; Deformity
    Keywords
    Positional Plagiocephaly, Nonsynostotic Plagiocephaly, Repositioning, Osteopathic Manipulative Treatment, Cranial asymetry

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Osteopathic Manipulative Treatment
    Arm Type
    Experimental
    Arm Description
    Patients will be treated once a week with OMT x 8 weeks
    Arm Title
    Standard of Care Repositioning
    Arm Type
    Active Comparator
    Arm Description
    Patients will only receive repositioning only x 8 weeks and all parents will receive standardized materials to counsel/instruct on the repositioning
    Intervention Type
    Procedure
    Intervention Name(s)
    Osteopathic Manipulative Treatment
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard of Care Repositioning
    Intervention Description
    Parents will receive standardized handouts/materials instructing on repositioning intended to help improve head shape in infants with plagiocephaly.
    Primary Outcome Measure Information:
    Title
    Cranial Vault Asymmetry Index
    Description
    Anthropometric measurement of cranial asymmetry
    Time Frame
    2 years
    Title
    Head circumference
    Description
    Standard growth parameter measured in infants
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Medical history
    Description
    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.
    Time Frame
    12 months
    Title
    Developmental Milestones
    Description
    Patients' enrolled in the study will have developmental stones monitored as per general pediatrician's protocol to screen for developmental delays.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    4 Months
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kimberly J Wolf, DO
    Phone
    19373699290
    Email
    wolfkimb@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kimberly J Wolf, DO
    Organizational Affiliation
    Osteopathy's Promise to Children
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates

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