Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-03-06 @ 8:05 AM
Study NCT ID:
NCT02307760
Status:
COMPLETED
Last Update Posted:
2017-05-11
First Post:
2014-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Human Milk Fortifiers in Preterm Infants
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-09', 'studyFirstSubmitDate': '2014-12-01', 'studyFirstSubmitQcDate': '2014-12-02', 'lastUpdatePostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight Gain', 'timeFrame': 'Study Day 1 to Study Day 29 (or discharge, whichever happens first)', 'description': 'scale measurement g/kg/d'}], 'secondaryOutcomes': [{'measure': 'Gastrointestinal Tolerance', 'timeFrame': 'Study Day 1 to Study Day 29 (or discharge, whichever happens first)', 'description': 'healthcare professional completed questionnaire'}, {'measure': 'Length', 'timeFrame': 'Study Day 1 to Study Day 29 (or discharge, whichever happens first)', 'description': 'measured cm/wk'}, {'measure': 'Head Circumference', 'timeFrame': 'Study Day 1 to Study Day 29 (or discharge, whichever happens first)', 'description': 'measured cm/wk'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infant Growth']}, 'referencesModule': {'references': [{'pmid': '31975350', 'type': 'DERIVED', 'citation': 'Paul M, Partridge J, Barrett-Reis B, Ahmad KA, Machiraju P, Jayapalan H, Schanler RJ. Metabolic Acidosis in Preterm Infants is Associated with a Longer Length of Stay in the Neonatal Intensive Care Unit. Pharmacoecon Open. 2020 Sep;4(3):541-547. doi: 10.1007/s41669-020-00194-y.'}, {'pmid': '30195561', 'type': 'DERIVED', 'citation': 'Schanler RJ, Groh-Wargo SL, Barrett-Reis B, White RD, Ahmad KA, Oliver J, Baggs G, Williams L, Adamkin D. Improved Outcomes in Preterm Infants Fed a Nonacidified Liquid Human Milk Fortifier: A Prospective Randomized Clinical Trial. J Pediatr. 2018 Nov;202:31-37.e2. doi: 10.1016/j.jpeds.2018.07.005. Epub 2018 Sep 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess growth of preterm infants fed human milk supplemented with one of two commercially available human milk fortifiers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Birth weight of 700 g-1500 g.\n* ≤ 32 weeks and 0 days GA at birth.\n* Appropriate for GA (AGA).\n* Enteral feeding of human milk initiated by 21 days of life (birth date is day of life 0).\n* Mother agrees to provide human milk as the exclusive feeding during the study period; use of donor milk is permitted if the plan is that it will be fortified.\n* Parent(s) agrees to allow infant to receive both human milk and HMF.\n* Singleton or twin births only.\n\nExclusion Criteria:\n\n* Enteral feeding of preterm infant formula or HMF for \\> 7 days.\n* Expected to be transferred to another facility and will not be able to be followed for at least 15 days.\n* Serious congenital abnormalities or underlying disease that may affect growth and development.\n* 5 minute APGAR ≤ 4.\n* Steroids used at the time of randomization.\n* Grade III or IV periventricular/intraventricular hemorrhage (PVH/IVH).\n* Mechanical ventilator dependence.\n* Maternal incapacity: including maternal cocaine or alcohol abuse during pregnancy or current, or if the mother or infant is currently receiving treatment consistent with HIV therapy.\n* Infant has a history of major surgery (intra-thoracic or intra-abdominal procedures or other surgery requiring general anesthesia).\n* Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia characterized by APGAR score \\<3 at 10 minutes, seizures within the first 12 hours of life, or a cord blood gas \\< 7.0 and seizures and/or severe tonic abnormalities in the first 12 hours of life (24).\n* Confirmed necrotizing enterocolitis (Bell's Stage II or III, Appendix J) or confirmed sepsis (positive culture requiring antibiotic treatment).\n* Infant has any other condition that, in the opinion of the investigator, precludes participation in the study.\n* Participation in another study that has not been approved as a concomitant study by AN."}, 'identificationModule': {'nctId': 'NCT02307760', 'briefTitle': 'Evaluation of Human Milk Fortifiers in Preterm Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Evaluation of Two Human Milk Fortifiers in Preterm Infants', 'orgStudyIdInfo': {'id': 'AL16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study Human Milk Fortifier A', 'description': 'Acidified processing method.', 'interventionNames': ['Other: Human Milk Fortifier A']}, {'type': 'EXPERIMENTAL', 'label': 'Study Human Milk Fortifier B', 'description': 'Non-acidified processing method.', 'interventionNames': ['Other: Human Milk Fortifier B']}], 'interventions': [{'name': 'Human Milk Fortifier A', 'type': 'OTHER', 'description': 'Acidified concentrated liquid human milk fortifier', 'armGroupLabels': ['Study Human Milk Fortifier A']}, {'name': 'Human Milk Fortifier B', 'type': 'OTHER', 'description': 'Non-acidified concentrated liquid human milk fortifier', 'armGroupLabels': ['Study Human Milk Fortifier B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': "University of South Alabama Children's and Women's Hospital", 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85014', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner - University Medical Center Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '06520-8064', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Medstar Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'South Miami Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': "All Children's Hospital / Johns Hopkins", 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '46601', 'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'Memorial Hospital of South Bend', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': "Cohen Children's Medical Center of NY at North Shore", 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': "Cohen Children's Medical Center of NY", 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lehigh Valley Health Network', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '78539', 'city': 'Edinburg', 'state': 'Texas', 'country': 'United States', 'facility': "Doctors Hospital at Renaissance/Women's Hospital at Renaissance", 'geoPoint': {'lat': 26.30174, 'lon': -98.16334}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': "Cook Children's Medical Center", 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Health and Education Institute', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'North Central Baptist Hospital', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '53210', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Wheaton Franciscan Heathcare Inc.- St. Joseph', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Bridget Barrett-Reis, PhD, RD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}