Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-01-02 @ 6:18 AM
Study NCT ID:
NCT01988792
Status:
COMPLETED
Last Update Posted:
2015-07-29
First Post:
2013-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Milk Fortification in Very Low Birth Neonates
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-28', 'studyFirstSubmitDate': '2013-11-12', 'studyFirstSubmitQcDate': '2013-11-13', 'lastUpdatePostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The days to reach full enteral feeding volume (140 ml/kg/day).', 'timeFrame': '4 - 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Neonatal Outcomes', 'timeFrame': 'until 36 weeks PMA', 'description': 'Necrotizing Enterocolitis'}, {'measure': 'Neonatal Outcomes', 'timeFrame': 'until 36 weeks PMA', 'description': 'Chronic Lung Disease'}, {'measure': 'Neonatal Outcomes', 'timeFrame': 'Until full feeding volume', 'description': 'Feeding intolerance'}, {'measure': 'Neonatal Outcomes', 'timeFrame': 'Until full feeding volume', 'description': 'Parental nutrition days'}, {'measure': 'Neonatal Outcomes', 'timeFrame': 'until 36 weeks PMA', 'description': 'Ventilator days'}, {'measure': 'Neonatal Outcomes', 'timeFrame': 'until 4 weeks of life', 'description': 'Protein and caloric intake'}, {'measure': 'Neonatal Outcomes', 'timeFrame': 'until 4 weeks of life', 'description': 'Growth anthropometry'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Premature; Infant', 'Enteral Nutrition', 'Human Milk', 'Fortification']}, 'referencesModule': {'references': [{'pmid': '27112041', 'type': 'DERIVED', 'citation': 'Shah SD, Dereddy N, Jones TL, Dhanireddy R, Talati AJ. Early versus Delayed Human Milk Fortification in Very Low Birth Weight Infants-A Randomized Controlled Trial. J Pediatr. 2016 Jul;174:126-131.e1. doi: 10.1016/j.jpeds.2016.03.056. Epub 2016 Apr 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study to find out how safely we can add extra nutrients to human milk at different feeding volume.', 'detailedDescription': "Very low birth weight babies (weight less than three pounds and three ounces) are extremely fragile and lacking important nutrition due to premature birth. They need enough calories for catch-up growth. Giving adequate nutrition is very important for their growth and development. Human milk is the best food, however it is not enough to provide all the required calories and nutrients for catch up growth and maintain adequate strength of the bones (bone mineralization). For premature babies, extra nutrients (human milk fortifier) are usually added to the human milk to provide adequate nutrition. These extra nutrients will be derived from cow's milk. Currently, a practice of fortifying human milk varies. There is no clear information when to start adding extra nutrients to human milk."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Days', 'minimumAge': '2 Days', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Very low birth weight infants who receive human milk (mother's milk or banked donor human milk).\n\nExclusion Criteria:\n\n* Major congenital anomalies such as cardiac defect, neural tube defect, chromosomal abnormality and gastrointestinal defect.\n* Died or extended to die within 48 hours of life"}, 'identificationModule': {'nctId': 'NCT01988792', 'briefTitle': 'Human Milk Fortification in Very Low Birth Neonates', 'organization': {'class': 'OTHER', 'fullName': 'University of Tennessee'}, 'officialTitle': 'Human Milk Fortification and Feeding Intolerance in Very Low Birth Weight Neonates', 'orgStudyIdInfo': {'id': '13-02741-FB'}, 'secondaryIdInfos': [{'id': '8671-2075', 'type': 'OTHER_GRANT', 'domain': 'Mead Johnson and Company LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fortification at 20 ml/kg/day feeding volume', 'description': 'Human milk fortifiers will be added to the human milk when neonates reach to feeding volume of 20 ml/kg/day.', 'interventionNames': ['Dietary Supplement: Human milk fortifiers']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fortification at 100 ml/kg/day feeding volume', 'description': 'human milk fortifiers will be added to the human milk when neonates reach to feeding volume of 100 ml/kg/day.', 'interventionNames': ['Dietary Supplement: Human milk fortifiers']}], 'interventions': [{'name': 'Human milk fortifiers', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Fortification at 100 ml/kg/day feeding volume', 'Fortification at 20 ml/kg/day feeding volume']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee, Health Science Center, The Regional Medical Center', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Sanket D Shah, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTHSC, Memphis, TN'}, {'name': 'Ajay J Talati, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTHSC, Memphis, TN'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tennessee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}