Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-01-02 @ 4:24 AM
Study NCT ID:
NCT05228535
Status:
UNKNOWN
Last Update Posted:
2022-07-21
First Post:
2022-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Milk in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-04', 'size': 548223, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-07-19T08:40', 'hasProtocol': True}, {'date': '2022-05-05', 'size': 781717, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-07-19T08:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 groups. 1 group will be controlled, following standard NICU feeding protocol. 1 group will be intervention, receiving early introduction of human milk fortifier to enteral feeds.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2022-01-14', 'studyFirstSubmitQcDate': '2022-01-27', 'lastUpdatePostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Growth velocity', 'timeFrame': 'at 28 days of life', 'description': 'weight gain in grams/kg/day'}], 'secondaryOutcomes': [{'measure': 'Growth velocity', 'timeFrame': 'at 36 weeks post menstrual age', 'description': 'weight gain in grams/kg/day'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm Birth']}, 'referencesModule': {'references': [{'pmid': '38724605', 'type': 'DERIVED', 'citation': 'Wynter Z, Gorham JA, Thompson AB, Mundy C, Waller JL, Stansfield BK. Immediate fortification of human milk with a bovine milk-derived human milk fortifier in very low birth weight infants: a randomized clinical trial. J Perinatol. 2024 Nov;44(11):1591-1596. doi: 10.1038/s41372-024-01998-0. Epub 2024 May 9.'}]}, 'descriptionModule': {'briefSummary': 'Current NICU protocol introduces human milk fortifier at 8 days of feeding. This study will introduce human milk fortifier at day 1. The primary outcome is the effect on growth velocity at 28 days and 36 weeks post menstrual age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Birth weight 1000-1500 grams\n* Admitted to NICU within 24 hours of life\n* Maternal intent to use human milk\n\nExclusion Criteria:\n\n* Congenital anomalies\n* Feeds not started within the first 96 hours of life\n* Intrauterine growth restriction'}, 'identificationModule': {'nctId': 'NCT05228535', 'briefTitle': 'Human Milk in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Augusta University'}, 'officialTitle': 'Early Fortification of Human Milk for Very Low Birth Weight Infants and Effects on Growth Velocity', 'orgStudyIdInfo': {'id': '1813934-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Continue current NICU feeding protocol, introducing human milk fortifier at 8 days'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Introducing human milk fortifier at 1 day', 'interventionNames': ['Dietary Supplement: Human milk fortifier']}], 'interventions': [{'name': 'Human milk fortifier', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Human milk fortifier added to human breast milk at day 1 vs day 8 of feeds', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Zanna Wynter, DO', 'role': 'CONTACT', 'email': 'zwynter@augusta.edu'}], 'facility': "Children's Hospital of Georgia", 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}], 'centralContacts': [{'name': 'Zanna Wynter, DO', 'role': 'CONTACT', 'email': 'zwynter@augusta.edu', 'phone': '770-608-0868'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Augusta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}