Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-03-02 @ 10:35 PM
Study NCT ID:
NCT03780920
Status:
COMPLETED
Last Update Posted:
2025-09-30
First Post:
2018-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventive Osteopathic Treatment of Plagiocephaly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}], 'ancestors': [{'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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2018-12-13', 'studyFirstSubmitQcDate': '2018-12-18', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positionnal skull deformation : plagiocephaly and brachycephaly', 'timeFrame': 'four month', 'description': 'cranial vault asymetry index and cranial index measured with caliper between the age of 3 to 10 days and at 4 months measured blind of the randomization arm'}], 'secondaryOutcomes': [{'measure': 'Questionnaire QUALIN', 'timeFrame': 'fourth month', 'description': 'the"questionnaire QUALIN" is a quality of life assessment questinniare for infant under 3 months of age, valided in Europe(French, Spanish, English and Italian)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Positilonal Deformation of the Skull', 'Head Turn Preference', 'Axial Hypertony']}, 'descriptionModule': {'briefSummary': 'Positional cranial deformities (PCD), plagiocephaly and brachycephaly are a common reason for pediatric consultation, which has increased significantly since the recommendation to lay babies on their backs to prevent unexpected infant death (ILD). CPD is a source of concern for parents about their impact on psychomotor development and the aesthetic risk of deformity. The High Authority for Health (HAS) will soon put in place recommendations with a fact sheet for health professionals and the public. The aim of this research is to study whether early treatment of rotation disorders and hypertonia in newborns by manual osteopathic techniques would prevent the occurrence of positional deformities of the skull.\n\nThe main objective is to evaluate the effectiveness of an early osteopathic treatment on the rate of CPP (plagiocephalic and postural brachycephalia) at 4 months in newborns at risk.\n\nthe secondary objective is: to evaluate the effectiveness of an early osteopathic treatment on the quality of life of the child at 4 months.\n\nMethodology: Controlled, randomized monocentric two-arm parallel study between (1) osteopathic follow-up and (2) osteopathy-free follow-up. The inclusion period will be 18 months and the follow-up period is 4 months.\n\nProcedure: The two groups will be evaluated at 3 days and 4 months. The experimental group will benefit from an osteopathic treatment of 3 days of life to 4 months with a frequency of 3 to 4 sessions. Both groups will benefit from sleeping, carrying, positioning and stimulation advice.\n\nThe perspectives are:\n\n* the decrease in the prevalence of CPP after early osteopathic treatment.\n* Defining a decision algorithm for early osteopathic treatment.\n* Subject to recommendations on the indication of early osteopathic treatment in neonates at risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Days', 'minimumAge': '3 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newborn baby aged 3 days and until the maternity leave\n* Newborn with at least one risk factor for cranial deformity:\n\n * Newborn who received instrumental vaginal delivery.\n * Newborn presenting:\n\n * a preferential side,\n * global axial hypertonia,\n * Localized suboccipital hypertonia\n * Newborn presenting:\n\n * cranial deformity at birth,\n * a deformation of the face,\n * deformity of the trunk in scoliosis, comma or hyperextension\n\nExclusion Criteria:\n\n* Newborn with congenital muscular torticollis (managed directly in physiotherapy)\n\n * Premature neonate (\\<37SA)\n * Newborn with a malformation pathology\n * Newborn with craniosynostosis.\n * Newborn with a contraindication to the practice of osteopathy.'}, 'identificationModule': {'nctId': 'NCT03780920', 'acronym': 'TOPP PLAGIO', 'briefTitle': 'Preventive Osteopathic Treatment of Plagiocephaly', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Interest of an Early Osteopathic Treatment in Infants in the Prevention of Cranial Deformations : Positional Plagiocephaly and Brachycephaly.', 'orgStudyIdInfo': {'id': 'RECHMPL18_0207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Osteopathic treatment', 'interventionNames': ['Procedure: manual therapy/osteopathy']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'manual therapy/osteopathy', 'type': 'PROCEDURE', 'description': 'In this group, children will benefit from early osteopathic treatment over a period ranging from the third day to 4 months. The number of sessions will not be fixed, on average, 3 sessions will be carried out during this period at the University Hospital of Montpellier.\n\nThe duration of the session will be between 20 minutes to 30 or even 40 minutes', 'armGroupLabels': ['Osteopathic treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Montpellier', 'state': 'Hérault', 'country': 'France', 'facility': 'CHU Arnaud de Villeneuve', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Guillaume CAPTIER, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}