Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT03586102
Status:
COMPLETED
Last Update Posted:
2025-05-28
First Post:
2018-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Increased Enteral Protein on Body Composition of 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Clinicians and technicians responsible for the assessment of infant body composition will be masked.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-26', 'studyFirstSubmitDate': '2018-06-01', 'studyFirstSubmitQcDate': '2018-07-02', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in intestinal microbiome', 'timeFrame': 'Birth to 3 months of corrected age', 'description': 'Determined by molecular analyses of bacteria in fecal samples'}, {'measure': 'Changes in metabolic pathways', 'timeFrame': 'Birth to 3 months of corrected age', 'description': 'Determined by molecular analyses of serum samples'}], 'primaryOutcomes': [{'measure': 'Infant body composition', 'timeFrame': 'Assessed at 36 weeks of postmenstrual age or at 3 months of corrected age', 'description': 'Percent body fat estimated by air displacement plethysmography'}], 'secondaryOutcomes': [{'measure': 'Infant body composition', 'timeFrame': 'Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first)', 'description': 'Percent body fat estimated by air displacement plethysmography'}, {'measure': 'Growth', 'timeFrame': 'Birth to 3 months of corrected age', 'description': 'Weekly weight gain in grams'}, {'measure': 'Length', 'timeFrame': 'Birth to 3 months of corrected age', 'description': 'Weekly length in cm'}, {'measure': 'Head circumference', 'timeFrame': 'Birth to 3 months of corrected age', 'description': 'Weekly head circumference in cm'}, {'measure': 'Body mass index', 'timeFrame': 'Birth to 3 months of corrected age', 'description': 'Weight and height will be combined to report BMI in kg/m\\^2'}, {'measure': 'Necrotizing enterocolitis', 'timeFrame': 'Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first', 'description': 'Number of participants with diagnosis of necrotizing enterocolitis stage 2 or 3'}, {'measure': 'Death', 'timeFrame': 'Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Protein supplementation', 'Human milk fortification'], 'conditions': ['Premature Infant']}, 'referencesModule': {'references': [{'pmid': '34183770', 'type': 'BACKGROUND', 'citation': 'Salas AA, Jerome M, Finck A, Razzaghy J, Chandler-Laney P, Carlo WA. Body composition of extremely preterm infants fed protein-enriched, fortified milk: a randomized trial. Pediatr Res. 2022 Apr;91(5):1231-1237. doi: 10.1038/s41390-021-01628-x. Epub 2021 Jun 28.'}]}, 'descriptionModule': {'briefSummary': 'The study hypothesis is that, in human milk-fed extremely preterm infants, higher protein intake compared to usual protein intake reduces percent body fat (%BF) at 3 months of age.', 'detailedDescription': 'Qualifying participants will be randomly assigned to receive either standard protein supplementation (control group) or high protein supplementation (intervention group).\n\nIntervention group: A fixed amount of commercially available hydrolyzed bovine protein will be added to fortified human milk after establishment of full enteral feeding.\n\nControl group: Hydrolyzed bovine protein will not be added to fortified human milk after establishment of full enteral feeding.\n\nIf parent agrees, stool "dirty" diapers will be collected 2 times (at the time of hospital discharge and at 3 months of corrected age).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '21 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age between 25 and 28 weeks of gestation\n* Feeding volumes of ≥120 ml/kg/day before or on postnatal day 14.\n\nExclusion Criteria:\n\n* Necrotizing enterocolitis (NEC) stage 2 or greater.\n* Gastrointestinal or neurologic malformations.\n* Terminal illness needing to limit or withhold support will be exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT03586102', 'briefTitle': 'Effect of Increased Enteral Protein on Body Composition of Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Effect of Increased Enteral Protein on Body Composition of Preterm Infants: A Randomized Trial', 'orgStudyIdInfo': {'id': '300000681'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High protein supplementation', 'description': "Infants will receive a diet that consists of mother's own milk or donor human milk and bovine-based human milk fortifier plus a fixed amount of commercially available hydrolyzed bovine protein. The study intervention will begin the day after fortification is ordered and will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first.", 'interventionNames': ['Dietary Supplement: High protein supplementation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard protein supplementation', 'description': "Infants will receive a standard diet that consists of mother's own milk or donor human milk (DHM) and bovine-based human milk fortifier. The study intervention will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first.", 'interventionNames': ['Dietary Supplement: Standard protein supplementation']}], 'interventions': [{'name': 'High protein supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'To increase protein content of human milk, a fixed amount of commercially available hydrolyzed bovine protein will be added to fortified human milk. With this pragmatic approach, preterm infants assigned to the high protein supplementation group will receive \\> 4.5 g/kg/day of enteral protein after establishment of full enteral feeding.', 'armGroupLabels': ['High protein supplementation']}, {'name': 'Standard protein supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Infants assigned to the standard protein supplementation group will receive fortified human milk (\\< 4.5 g/kg/day of enteral protein)', 'armGroupLabels': ['Standard protein supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Ariel A. Salas, MD, MSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Health System, Alabama", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ariel A. Salas', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}