Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-01-16 @ 7:17 PM
Study NCT ID:
NCT01890668
Status:
COMPLETED
Last Update Posted:
2016-11-28
First Post:
2013-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Assessment of Osteopathic Manipulative Treatment in the Suboptimal Breastfeeding Behaviour
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-25', 'studyFirstSubmitDate': '2013-06-21', 'studyFirstSubmitQcDate': '2013-06-27', 'lastUpdatePostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy assessment of osteopathic treatment on breastfeeding failure at 1 month of life.', 'timeFrame': 'at 1 month of life.', 'description': 'compare of breastfeeding failure percentage at one month of life between the two arms'}], 'secondaryOutcomes': [{'measure': 'Compare IBFAT score (Infant Breast Feeding Assessment Tool score)', 'timeFrame': 'at 10 days of life', 'description': 'compare the IBFAT score between the two consultation Cs1(day 3) and Cs2 (day 10)'}, {'measure': 'Maternal satisfaction assessment', 'timeFrame': 'at one month of life', 'description': 'assessment of maternal satisfaction between the Cs1, Cs2 and the visit at one month, by VAS'}, {'measure': 'Safety assessment measured by per-treatment DAN score', 'timeFrame': 'at 3 days of life'}, {'measure': 'Preventive efficacy of osteopathic treatment on nipple cracks, measured by the number of nipple cracks', 'timeFrame': 'at one month of life'}, {'measure': 'Description of newborns behaviour during the first month of life (sleeping/awakening rhythm, cries and breastfeeding durations etc…) according treatment arm.', 'timeFrame': 'at one month of life'}, {'measure': 'Description of breastfeeding initiation during the first month of life.', 'timeFrame': 'at one month of life'}, {'measure': 'Assessment of differential efficacy according osteopathic practitioner profile (age/experience, perinatal specialization…)', 'timeFrame': 'at 10 days of life'}, {'measure': 'Description of osteopathic dysfunctions frequencies diagnosed by osteopath.', 'timeFrame': 'at 10 days of life'}, {'measure': 'Safety assessment measured by per-treatment DAN score', 'timeFrame': 'at 10 days of life'}, {'measure': 'Curative efficacy of osteopathic treatment on nipple cracks, measured by the number of nipple cracks', 'timeFrame': 'at one month of life'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breastfeeding behaviour', 'OMT (Osteopathic Manipulative Treatment)', 'suboptimal infant breastfeeding behaviour', 'healthy newborns'], 'conditions': ['Breast Feeding, Exclusive']}, 'referencesModule': {'references': [{'pmid': '33789971', 'type': 'DERIVED', 'citation': 'Danielo Jouhier M, Boscher C, Roze JC, Cailleau N, Chaligne F, Legrand A, Flamant C, Muller JB; NEOSTEO osteopath study group. Osteopathic manipulative treatment to improve exclusive breast feeding at 1 month. Arch Dis Child Fetal Neonatal Ed. 2021 Nov;106(6):591-595. doi: 10.1136/archdischild-2020-319219. Epub 2021 Mar 31.'}]}, 'descriptionModule': {'briefSummary': 'Breastfeeding is one of the prime factors of long-term health protection in newborns, for nutritional, immunological and developmental reasons. In France there is a wide inter-regional variability of breastfeeding rates at discharge. This variability associates different factors involving both, mothers, birth conditions, newborns and mother-child couple. Some approaches, including osteopathy, aim to support early breastfeeding difficulties. As many others non-conventional medicines, there is a huge and growing interest for this alternative therapy and a spontaneous recourse in the first months of life. Nevertheless, neither efficacy nor the benefits have been studied. Thus, our objective is to evaluate for the first time in France, in a randomized, double-blinded design, the efficacy of early osteopathic manipulative treatment (OMT), in suboptimal breastfeeding behaviour healthy newborns.\n\n128 couples mother-child will be randomized in two groups: with or without osteopathic intervention on the newborn.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy newborn ≥ 38 weeks of gestation,\n* Suboptimal breastfeeding behavior defined by an IBFATmax score \\<10 after 2 assessments.(IBFATmax score = maximal score of Infant Breast Feeding Assessment Tool)\n* And/ or presence of persistent severe pain (VAS\\> 5) at hospital discharge,\n* And / or the presence of nipples cracks, grades 2-5 on the NTS scale\n* Maternal Project of exclusive breastfeeding.\n* Parental informed and consent form signed\n\nExclusion Criteria:\n\n* Prematurity defined by a gestation \\<38 weeks\n* Hypotrophy\n* Maternal obesity (BMI\\>40)\n* Multiple pregnancy\n* Congenital malformation\n* Neonatal pathology incompatible with efficient lactation initiation.\n* Mothers minor or major and / or under guardianship and / or with poor understanding of French language\n* Previous history of maternal breast surgery or umbilicated nipple\n* IBFAT score max \\>10 on at least one of the two assessment at Day3.\n* Medical contraindication to osteopathy: bone injury (fracture), tendon or ligament (sprain, dislocation etc ...) in the newborn incompatible with effective mobilization.\n* Parental consent withdrawal.\n* Neonatal pathology incompatible with breastfeeding follow-up in the first month of life.'}, 'identificationModule': {'nctId': 'NCT01890668', 'acronym': 'NEOSTEO', 'briefTitle': 'Efficacy Assessment of Osteopathic Manipulative Treatment in the Suboptimal Breastfeeding Behaviour', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Efficacy Assessment of Early Osteopathic Manipulative Treatment (OMT) in the Management of Suboptimal Breastfeeding Behaviour in Healthy Newborns. A Prospective Monocentric Randomized Double-blinded Study.', 'orgStudyIdInfo': {'id': 'RC12_0379'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Osteopathic Manipulative Treatment', 'description': 'Randomization and first OMT will take place at discharge (Day 3); second osteopathic therapy will be performed by the same osteopath practitioner at Day10.', 'interventionNames': ['Other: Osteopathic Manipulative Treatment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Control group consists in classical medical and paramedical breastfeeding support. OMT on the newborn will be realized by osteopath dissimulated behind a screen. Placebo OMT consists to mimic, without the knowledge of parents, osteopathic techniques on a dolly.', 'interventionNames': ['Other: No Osteopathic manipulative Treatment']}], 'interventions': [{'name': 'Osteopathic Manipulative Treatment', 'type': 'OTHER', 'description': 'Visit 1 between H60 and discharge :\n\nInterview (pregnancy step, initiation of breastfeeding, baby posture…) Osteopathic Clinical exam (osteopathic specific diagnosis, mobility…) Osteopathic Manipulative Treatment by sweet osteopathic mobilization Time of intervention = 30 to 45 min Visit 2 : 7 days after visit 1 (+/- 24H) with the same procedure\n\nTo keep the blinded procedure the interventions will be realized behind a screen, allowing interactions with parents but depriving their visibility.\n\nA telephone contact will be perform at M1 (one month of life) to assess breastfeeding persistence and collect questionnaire data.\n\nTwo others telephone contacts will be perform at 3 months and 6 months to precise breastfeeding interruption date.\n\nThe follow-up for each patient is 6 months', 'armGroupLabels': ['Osteopathic Manipulative Treatment']}, {'name': 'No Osteopathic manipulative Treatment', 'type': 'OTHER', 'description': 'Visit 1 between H60 and discharge :\n\nInterview (pregnancy steps, initiation of breastfeeding, baby posture…) Osteopathic Clinical exam and Treatment will not be realized. Newborn will be undressed, lying naked (covered with polar sheet) on the exam table, dissimulated to parents by adequate screen. The osteopathic procedure will take place on a dolly to mimic from an indiscernible manner, osteopathic management.\n\nTime of intervention = 30 to 45 min Visit 2: 7 days after visit 1 (+/- 24H) with the same procedure.\n\nTo keep the blinded procedure the interventions will be realized behind a screen, allowing interactions with parents but depriving their visibility.\n\nA telephone contact will be perform at M1 (one month of life) to assess breastfeeding persistence and collect questionnaire data.\n\nTwo others telephone contacts will be perform at 3 months and 6 months to precise breastfeeding interruption date.\n\nThe follow-up for each patient is 6 months', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nantes - Hôpital Mère-Enfant', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Jean-Baptiste MULLER, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nantes, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}