Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT06723067
Status:
RECRUITING
Last Update Posted:
2024-12-09
First Post:
2024-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Trial of Impact of Wearable, Wireless Breast Pumps on Frequency and Efficacy of Milk Expression in Mothers of Premature Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2024-12-03', 'studyFirstSubmitQcDate': '2024-12-03', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of pumping sessions per day', 'timeFrame': '7 days', 'description': 'Number of milk pumping sessions per day'}], 'secondaryOutcomes': [{'measure': 'Volume of milk pumped per day', 'timeFrame': '7 days', 'description': 'Volume of breast milk pumped per day'}, {'measure': 'Percentage of required volume pumped', 'timeFrame': '7 days', 'description': 'Percentage of infants daily required milk volume which was pumped per day'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['premature birth', 'lactation'], 'conditions': ['Premature Birth']}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial of impact of wearable, wireless breast pumps on how often and how much milk mothers of premature infants can pump.', 'detailedDescription': 'Randomized, controlled crossover study design. Non-blinded. Mother of infants born at or below 29+6 weeks of gestation will be eligible once their infant is 28 or more days old. Mothers will be provided with a wearable, wireless breast pump in addition to their usual hospital grade pump. Wireless pumps can be used while cuddling their baby, driving too and from the hospital, caring for other children, etc.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mother of infant born at 29+6 weeks or below\n* Mother still pumping at 4 weeks since birth\n\nExclusion Criteria:\n\n* Current use of mothers own wearable pump'}, 'identificationModule': {'nctId': 'NCT06723067', 'acronym': 'MTMM', 'briefTitle': 'A Randomized Controlled Trial of Impact of Wearable, Wireless Breast Pumps on Frequency and Efficacy of Milk Expression in Mothers of Premature Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'More Time More Milk - Wearable, Wireless Breast Pumps to Increase Accessibility of Milk Expression for NICU Mothers', 'orgStudyIdInfo': {'id': 'STUDY00005474'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Wearable wireless pump provided in week one', 'description': 'Provision of a wearable, wireless pump in week one with support from a lactation specialist, standard of care in week two.', 'interventionNames': ['Device: Wearable wireless breast pump']}, {'type': 'OTHER', 'label': 'Wearable wireless pump provided in week two', 'description': 'Standard of care in week one, provision of a wearable, wireless pump in week two with support from a lactation specialist.', 'interventionNames': ['Device: Wearable wireless breast pump']}], 'interventions': [{'name': 'Wearable wireless breast pump', 'type': 'DEVICE', 'description': 'As above', 'armGroupLabels': ['Wearable wireless pump provided in week one', 'Wearable wireless pump provided in week two']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erica Ortiz', 'role': 'CONTACT', 'email': 'erica.ortiz@ascension.org', 'phone': '512-324-1085'}], 'facility': 'Ascension Seton Medical Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'centralContacts': [{'name': 'Erica Ortiz', 'role': 'CONTACT', 'email': 'erica.ortiz@ascension.org', 'phone': '512-324-1085'}], 'overallOfficials': [{'name': 'Alan Groves', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas at Austin'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': '12/02/2024, for 2 years', 'ipdSharing': 'YES', 'description': 'IPD can be shared at the request of other investigators'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}