Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-01 @ 3:23 PM
Study NCT ID:
NCT06691932
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2024-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
At-the-Breast vs. Expressed Human Milk: Genesis of Infant Nutrition (BEGIN)
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': 'ESTIMATED', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2024-11-13', 'studyFirstSubmitQcDate': '2024-11-13', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infant Sleep Latency', 'timeFrame': 'Baseline, 2 months and 4 months', 'description': 'The time to fall asleep after bedtime(minutes)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Feeding', 'Exclusive Breastfeeding']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to define human milk (HM) as an ecosystem which investigators will then combine into temporal models of milk dynamics to accurately describe HM chronobiology. This study addresses 4 crucial public health gaps: 1) how breast milk changes over time and over the day, 2) how milk dynamics are related to infant sleep patterns, 3) how milk dynamics are related to infant microbiome dynamics, and 4) how all these relationships differ between infants fed directly at-the-breast vs pumped milk. These fundamental insights have been unknown until now, so that families who feed pumped breast milk are completely underserved. These results are critical to optimizing infant feeding and health outcomes for all infants receiving breast milk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '0 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '240 mother/infant dyads exclusively feeding HM to healthy infants between 1-5 months postpartum: 120 mothers primarily feeding ATB (ATB Group) and 120 mothers predominantly feeding expressed HM (Express Group)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lactating mothers between 20-40 years old at enrollment\n\n o 120 mother/infant dyads who primarily feed HM ATB (average \\>75% of feeds,\n* pumping no more than one time per day)\n\n o 120 mother/infant dyads who predominantly feed expressed HM (average \\>75% of feeds)\n* All races and ethnicities may enroll\n* Singleton infant delivered after 37 weeks\n* Infant between the ages of 0-1 months at the time of enrollment.\n* No serious health complications in mother or infant\n\nExclusion Criteria:\n\n* Non-English-speaking subjects as study personnel only speak English\n* Lactating moms who will be feeding both ATB and expressed HM (over 25% of the time in either feeding mode)\n* Infant supplementation with formula ≥10 oz before sample collections begin, and/or no more than 16 oz during active participation/ sample collections.'}, 'identificationModule': {'nctId': 'NCT06691932', 'acronym': 'BEGIN', 'briefTitle': 'At-the-Breast vs. Expressed Human Milk: Genesis of Infant Nutrition (BEGIN)', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'At-the-Breast vs. Expressed Human Milk: Genesis of Infant Nutrition (BEGIN)', 'orgStudyIdInfo': {'id': 'STUDY00007528'}, 'secondaryIdInfos': [{'id': 'R01HD112363', 'link': 'https://reporter.nih.gov/quickSearch/R01HD112363', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mothers primarily feeding their baby expressed HM (Express Group)'}, {'label': 'Mothers primarily feeding their baby directly at-the-breast (ATB Group)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kaili Widrick, MS', 'role': 'CONTACT', 'email': 'kaili_widrick@urmc.rochester.edu', 'phone': '5852758991'}], 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'centralContacts': [{'name': 'Kaili Widrick, MS', 'role': 'CONTACT', 'email': 'Kaili_widrick@urmc.rochester.edu', 'phone': '5852758991'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Bridget Young', 'investigatorAffiliation': 'University of Rochester'}}}}