Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT01208493
Status:
TERMINATED
Last Update Posted:
2015-03-26
First Post:
2010-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dietary Protein in the Very-low-birth-weight Infant
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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-25', 'studyFirstSubmitDate': '2010-09-22', 'studyFirstSubmitQcDate': '2010-09-23', 'lastUpdatePostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison of weight gain between both study groups as a measure of safety', 'timeFrame': '3 weeks'}], 'secondaryOutcomes': [{'measure': 'comparison of feeding tolerance and metabolic status between study groups as a measure of safety', 'timeFrame': '3 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prematurity', 'enteral feeding', 'proteins', 'formula'], 'conditions': ['Prematurity']}, 'descriptionModule': {'briefSummary': 'In this randomized study The investigators aim to compare the growth of very-low-birth-weight (VLBW) infants fed either a high protein or a standard protein preterm infant formula.\n\nBabies will be fed the assigned formula between the time they achieve full enteral feeds and hospital discharge, for a minimum of 3 weeks. The weight gain (g/d) will be measured and compared between groups. Feeding tolerance, protein-energy status and body composition between the study groups will also be analysed.\n\nAfter discharge, babies will be fed a post-discharge preterm infant formula (PDF) between hospital discharge and 3 m corrected age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Weeks', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age \\<32 w, determined by maternal dates, fetal ultrasound, Dubowitz/Ballard examination or a combination thereof\n* Birth weight ≤1500 g\n* Tolerating an enteral intake of ≥100 ml/kg/d for ≥ 24 h\n* Subject is anticipated to receive the study formula for ≥ 3 consecutive weeks after FEF have been achieved\n* In infants fed human milk, formula is anticipated to provide 50% or more of total energy intake, calculated on a weekly basis and based on the assumption that human milk has an energy density of 67 kcal/dl\n* Written informed consent has been obtained from the legal representative\n\nExclusion Criteria:\n\n* Cardiac failure requiring fluid restriction with diuretic therapy for ≥ 3 consecutive days\n* Peri-/intra-ventricular haemorrhage (grade 3-4) determined using cranial ultrasonography\n* Renal disease: by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased BUN and creatinine\n* Sepsis: defined by symptoms requiring antibiotic therapy and confirmed by a positive blood culture\n* Necrotizing Enterocolitis: defined by feeding intolerance associated with positive x-ray findings (pneumatosis intestinalis - Bell Stage 2; air in the biliary tract or free air in the peritoneum - Bell Stage 3)\n* Hepatic dysfunction: defined by jaundice (direct bilirubin \\>1.0 mg/dl) which is associated with one or more abnormal liver function tests (AST, ALT or GGT)\n* Lung disease, severe enough to require steroid therapy.\n* Small size for gestational age (SGA) - body weight ≤ 5th percentile for that gestational age.\n* Participation in another clinical trial that may affect outcomes of this study'}, 'identificationModule': {'nctId': 'NCT01208493', 'briefTitle': 'Dietary Protein in the Very-low-birth-weight Infant', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Dietary Protein in the Very-low-birth-weight Infant: Effects of the Level of Dietary Protein on Growth and Feeding Tolerance', 'orgStudyIdInfo': {'id': '04.26.INF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high protein preterm infant formula', 'description': 'preterm infant formula with high protein levels', 'interventionNames': ['Other: preterm infant formula with high protein levels']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control preterm formula', 'interventionNames': ['Other: preterm standard infant formula']}], 'interventions': [{'name': 'preterm infant formula with high protein levels', 'type': 'OTHER', 'description': 'minimum 3 weeks feeding until hospital discharge', 'armGroupLabels': ['high protein preterm infant formula']}, {'name': 'preterm standard infant formula', 'type': 'OTHER', 'description': 'minimum 3 weeks feeding until hospital discharge', 'armGroupLabels': ['control preterm formula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Department of Pediatrics St Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Service Universitaire de Néonatologie CHR de la Citadelle', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '69317', 'city': 'Lyon', 'country': 'France', 'facility': 'Service de néonatologie Hôpital de la Croix Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': 'NE1 4LP', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Department of Child Health Royal Victoria Infirmary', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Richard J Cooke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pediatrics St Louis University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}