Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-02 @ 12:03 PM
Study NCT ID:
NCT07260968
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Facilitating Lactation Through Optimized Workflows - Evaluating the Efficiency of Pumping Protocols and Cellular Mechanisms of Milk Production
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 225}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2025-11-21', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Milk Production', 'timeFrame': '6 month follow-up', 'description': 'The study will measure milk production using a 24-hour test weighing (weighing infants before and after each feed) before and after the intervention.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Milk Supply']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of two different breast pumping protocols in increasing milk production among lactating individuals diagnosed with primary low milk supply, and to investigate the associated molecular, hormonal, and inflammatory mechanisms driving milk output.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English-speaking\n* Lactating parents of singleton, term infants less than 3 months of age\n* Intend to breastfeed and are breastfeeding (at the breast) at least 3 times per day\n\nExclusion criteria:\n\n* Twins and other multiples\n* Contraindications to or unable to breastfeed\n* Major congenital anomaly or unexpected surgery\n* Elevated maternal depression\n* Low milk transfer\n* No electricity or smartphone access'}, 'identificationModule': {'nctId': 'NCT07260968', 'acronym': 'FLOW', 'briefTitle': 'Facilitating Lactation Through Optimized Workflows - Evaluating the Efficiency of Pumping Protocols and Cellular Mechanisms of Milk Production', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Facilitating Lactation Through Optimized Workflows - Evaluating the Efficiency of Pumping Protocols and Cellular Mechanisms of Milk Production', 'orgStudyIdInfo': {'id': 'STUDY00011127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pumping 6-8 times a day (also known as triple-feeding protocol)', 'interventionNames': ['Other: Pumping frequency intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Pumping 3-4 times a day (lower frequency of pumping)', 'interventionNames': ['Other: Pumping frequency intervention']}, {'type': 'EXPERIMENTAL', 'label': 'No additional pumping will be recommended (mothers can choose to pump as they desire)', 'interventionNames': ['Other: Pumping frequency intervention']}], 'interventions': [{'name': 'Pumping frequency intervention', 'type': 'OTHER', 'description': 'In this randomized clinical trial, we will evaluate whether a lower frequency of pumping (3-4 times/day) or no additional pumping recommendations can lead to higher compliance, an increase in milk production, and a longer duration of breastfeeding.', 'armGroupLabels': ['No additional pumping will be recommended (mothers can choose to pump as they desire)', 'Pumping 3-4 times a day (lower frequency of pumping)', 'Pumping 6-8 times a day (also known as triple-feeding protocol)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cornell University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MPH, MSEd, NABBLM-C, FABM', 'investigatorFullName': 'Casey Rosen-Carole', 'investigatorAffiliation': 'University of Rochester'}}}}