Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-02-25 @ 4:37 PM
Study NCT ID:
NCT02407860
Status:
COMPLETED
Last Update Posted:
2015-12-22
First Post:
2015-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of an Osteopathic Treatment for Mechanical Sucking Dysfunctions in Newborn
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-21', 'studyFirstSubmitDate': '2015-03-10', 'studyFirstSubmitQcDate': '2015-04-02', 'lastUpdatePostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change from baseline in baby's latch at the breast", 'timeFrame': 'Immediately after the intervention and 2 days post-intervention', 'description': 'Latch assessment tool (Jensen, Wallace \\& Kelsay; 1994)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in numbers of feeds per day', 'timeFrame': 'Immediately after the intervention and 2, and 10 days post-intervention', 'description': 'Home made questionnaire with close-ended questions'}, {'measure': 'Change from baseline in devices used to feed the baby', 'timeFrame': '2 and 10 days post-intervention', 'description': 'Home made questionnaire with open-ended and close-ended questions, including the number of bottles the day before.'}, {'measure': "Change from baseline in mother's nipple pain", 'timeFrame': 'Immediately after the intervention and 2, and 10 days post-intervention', 'description': 'Visual analog scale from 0 (no pain) to 10 (extreme pain)'}, {'measure': "Change from baseline in baby's head rotation", 'timeFrame': 'Immediately after the intervention', 'description': "Assessment of baby's ability to rotate his/her head on left and right compared to a baseline evaluation prior to the intervention, using a goniometer"}, {'measure': "Mother's satisfaction with an osteopathic approach", 'timeFrame': '10 days post-intervention', 'description': "Likert scale to assess the mother's perception of an osteopathic approach with four items: not at all satisfied, somewhat satisfied, satisfied and very satisfied"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast feeding', 'sucking', 'dysfunction', 'Latch assessment tool', 'visual analogic scale', 'infant physiology'], 'conditions': ['Breastfeeding']}, 'descriptionModule': {'briefSummary': "Breastfeeding is the physiological and recommended way of feeding newborns as indicated by the World Health Organization, Health Canada and the politics of perinatality 2008-2018 in Quebec. Despite these, mothers who exclusively breastfed their babies are rare. According to Statistics Canada, the first month of life is the most at risk time to wean because of technical difficulties (53% of weaning) including mechanical issues. In Quebec city, despite a supportive network of health care professionals including lactation consultant, many babies are weaned. Lactation consultant are often feeling helpless when facing these mechanical difficulties.\n\nThe purpose of this study is to determine the efficiency of an osteopathic treatment for newborns presenting breastfeeding mechanical difficulties. The investigators' hypotheses is that an osteopathic treatment integrating in the usual care is more efficient than usual car alone to help healing mechanical breastfeeding issues.\n\nThe investigators propose a randomized clinical trial on a sample of 90 babies (45 in each group), under six weeks, presenting sucking dysfunctions, in Quebec city (Canada). The control group will receive usual care with a lactation consultant and the intervention group will receive usual care plus an osteopathic treatment. It is a simple blind clinical trial: the osteopath finds out, prior to evaluating the patient, what intervention should be delivered to the baby (assessment alone or standardized osteopathic treatment for infant).\n\nThe results will ultimately lead to improvements in the existing knowledge on the fields of osteopathy and lactation support, allowing implementation of osteopathic care in the perinatal network."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Weeks', 'minimumAge': '48 Hours', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy term newborn,\n* mechanical suckling dysfunction, assessed by lactation consultant or midwives or healthcare professionals with breastfeeding experience.\n\nExclusion Criteria:\n\n* breastfeeding difficulties from mother (hypogalactia, breast hypoplasia, medication),\n* twins or more,\n* tongue-tie or lip tie pending for surgical treatment,\n* previous or current bodywork (chiropractic, osteopathy, physiotherapy, ergotherapy, craniosacral therapy).'}, 'identificationModule': {'nctId': 'NCT02407860', 'briefTitle': 'Efficacy of an Osteopathic Treatment for Mechanical Sucking Dysfunctions in Newborn', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Efficacy of an Osteopathic Treatment for Mechanical Sucking Dysfunctions in Newborn', 'orgStudyIdInfo': {'id': '14-116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment', 'description': 'one single osteopathic treatment in addition to usual breastfeeding counselling', 'interventionNames': ['Other: osteopathic treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'usual breastfeeding counselling. Osteopathic evaluation of entire body', 'interventionNames': ['Other: usual breastfeeding counselling']}], 'interventions': [{'name': 'osteopathic treatment', 'type': 'OTHER', 'description': 'Treatment duration range between 30 to 40 minutes. The infant entire body is evaluated and then manipulative procedures are provided following palpatory results.', 'armGroupLabels': ['treatment']}, {'name': 'usual breastfeeding counselling', 'type': 'OTHER', 'description': 'breastfeeding counselling and support by lactation consultant', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1S 3S5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Entraide Naturo-Lait', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Isabelle Gaboury, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Université de Sherbrooke'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Isabelle Gaboury', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}