Ignite Creation Date:
2025-12-17 @ 2:47 PM
Ignite Modification Date:
2025-12-23 @ 10:01 PM
Study NCT ID:
NCT05848895
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2023-04-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D049068', 'term': 'Plagiocephaly, Nonsynostotic'}, {'id': 'D059041', 'term': 'Plagiocephaly'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026301', 'term': 'Manipulation, Osteopathic'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 122}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2023-04-28', 'studyFirstSubmitQcDate': '2023-04-28', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cranial Vault Asymmetry Index', 'timeFrame': '2 years', 'description': 'Anthropometric measurement of cranial asymmetry'}, {'measure': 'Head circumference', 'timeFrame': '2 years', 'description': 'Standard growth parameter measured in infants'}, {'measure': 'Weight', 'timeFrame': '2 years', 'description': 'Standard growth parameter measured in infants'}], 'secondaryOutcomes': [{'measure': 'Medical history', 'timeFrame': '12 months', '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.'}, {'measure': 'Developmental Milestones', 'timeFrame': '12 months', 'description': "Patients' enrolled in the study will have developmental stones monitored as per general pediatrician's protocol to screen for developmental delays."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Positional Plagiocephaly', 'Nonsynostotic Plagiocephaly', 'Repositioning', 'Osteopathic Manipulative Treatment', 'Cranial asymetry'], 'conditions': ['Plagiocephaly, Nonsynostotic', 'Plagiocephaly, Positional', 'Plagiocephaly', 'Cranium; Deformity']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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:\n\n1. Those who receive OMT with emphasis on osteopathic cranial manipulative medicine (OCMM) to restore cranial symmetry.\n2. 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).\n\nTimeline: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Months', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusions:\n\n* Diagnosed with positional plagiocephaly\n* Under 4-months of age (between birth - 4 months) at the time of enrollment\n\nExclusions:\n\n* Preterm birth (\\<37 weeks)\n* Genetic syndromes\n* Craniofacial defects/deformities (e.g. cleft lip/palate)\n* Brachycephaly/scaphocephaly\n* Hypotonia\n* Hypertonia\n* Craniosynostosis\n* Head trauma or other neurological illnesses\n* Lost to follow up\n* Patient whose parents (or legal guardians) disagree to attend 8-treatments of OMT and 2 additional measurement sessions\n* Prior helmet therapy, physical therapy, or OMT before the date of enrollment'}, 'identificationModule': {'nctId': 'NCT05848895', 'acronym': 'OPT-IN', 'briefTitle': 'OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates', 'organization': {'class': 'OTHER', 'fullName': "Osteopathy's Promise to Children"}, 'officialTitle': 'OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates', 'orgStudyIdInfo': {'id': 'OPC001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Osteopathic Manipulative Treatment', 'description': 'Patients will be treated once a week with OMT x 8 weeks', 'interventionNames': ['Procedure: Osteopathic Manipulative Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care Repositioning', 'description': 'Patients will only receive repositioning only x 8 weeks and all parents will receive standardized materials to counsel/instruct on the repositioning', 'interventionNames': ['Behavioral: Standard of Care Repositioning']}], 'interventions': [{'name': 'Osteopathic Manipulative Treatment', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['Osteopathic Manipulative Treatment']}, {'name': 'Standard of Care Repositioning', 'type': 'BEHAVIORAL', 'description': 'Parents will receive standardized handouts/materials instructing on repositioning intended to help improve head shape in infants with plagiocephaly.', 'armGroupLabels': ['Standard of Care Repositioning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Martone, PhD, MSW', 'role': 'CONTACT', 'email': 'jessica.martone@the-promise.org', 'phone': '619-693-6303'}, {'name': 'Kimberly Wolf, DO', 'role': 'CONTACT', 'email': 'kimberly.wolf@the-promise.org', 'phone': '619-693-6303'}, {'name': 'Kimberly Wolf, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Osteopathic Center San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'centralContacts': [{'name': 'Kimberly J Wolf, DO', 'role': 'CONTACT', 'email': 'kimberly.wolf@the-promise.org', 'phone': '619-583-7611'}, {'name': 'Jessica Martone, PhD, MSW', 'role': 'CONTACT', 'email': 'jessica.martone@the-promise.org', 'phone': '619-693-6303'}], 'overallOfficials': [{'name': 'Kimberly J Wolf, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Osteopathy's Promise to Children"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Osteopathy's Promise to Children", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Kimberly Wolf, DO', 'investigatorFullName': 'Kimberly Wolf', 'investigatorAffiliation': "Osteopathy's Promise to Children"}}}}