Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-03-13 @ 11:05 PM
Study NCT ID:
NCT02819193
Status:
COMPLETED
Last Update Posted:
2016-06-30
First Post:
2016-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Mother's Raw Milk Could Improve Breastfeeding in Hospitalized Neonates
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 665}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-29', 'studyFirstSubmitDate': '2016-06-28', 'studyFirstSubmitQcDate': '2016-06-29', 'lastUpdatePostDateStruct': {'date': '2016-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal breastfeeding', 'timeFrame': 'up to 6 months', 'description': 'Maternal breastfeeding is defined as the consumption of any MOM. It is classed as "exclusive" when all the fed milk will be MOM or "partial" when it will be completed by other milk or food.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breastfeeding', "mother's milk", 'breast milk', 'raw milk', 'neonate', 'Neonatal intensive care unit (NICU)'], 'conditions': ['Breastfeeding']}, 'descriptionModule': {'briefSummary': "Despite the importance of breast milk for sick or preterm neonates, there is currently no consensus regarding the use of raw mother's own milk (MOM) in neonatal units. The aims of this study are to: (a) describe factors associated with the use of raw MOM; (b) investigate the association between early use of raw MOM and breastfeeding continuation at discharge and up to 6 months later."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '42 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Neonates from two French participating centres.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted neonates between April 2012 and June 2013 are eligible if they are intended to be breastfeed and hospitalized ≥7 days\n\nExclusion Criteria:\n\n\\- Neonates with parents not fluent in French.'}, 'identificationModule': {'nctId': 'NCT02819193', 'acronym': 'DOAL', 'briefTitle': "Using Mother's Raw Milk Could Improve Breastfeeding in Hospitalized Neonates", 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': "Using Mother's Raw Milk Could Improve Breastfeeding in Hospitalized Neonates", 'orgStudyIdInfo': {'id': '69HCL16_0379'}}, 'armsInterventionsModule': {'armGroups': [{'label': "exposed group : early raw mother's own milk", 'description': 'The use of raw MOM is considered as "early" when it begins before day 7.', 'interventionNames': ["Other: raw mother's own milk"]}, {'label': "unexposed group : no use of raw mother's own milk", 'description': 'Neonates who receive, or not, raw MOM before day 7.'}], 'interventions': [{'name': "raw mother's own milk", 'type': 'OTHER', 'description': "Infants receive mother's own milk before day 7.", 'armGroupLabels': ["exposed group : early raw mother's own milk"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'country': 'France', 'facility': 'Service de Réanimation Néonatale et Néonatologie, Hôpital Femme Mère Enfant, 32 Avenue Doyen Jean Lépine', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'overallOfficials': [{'name': 'Céline Fischer Fumeaux, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Réanimation Néonatale et Néonatologie, Hôpital Femme Mère Enfant, Bron, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}