Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-02-21 @ 9:56 AM
Study NCT ID:
NCT01773902
Status:
COMPLETED
Last Update Posted:
2018-05-15
First Post:
2013-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protein for Premies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011506', 'term': 'Proteins'}], 'ancestors': [{'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-09', 'studyFirstSubmitDate': '2013-01-15', 'studyFirstSubmitQcDate': '2013-01-18', 'lastUpdatePostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Plasma amino acid profile', 'timeFrame': 'at 2 and 4 weeks after start of intervention'}], 'primaryOutcomes': [{'measure': 'Weight gain', 'timeFrame': 'From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA)'}], 'secondaryOutcomes': [{'measure': 'Head circumference growth', 'timeFrame': 'From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Extreme Prematurity']}, 'referencesModule': {'references': [{'pmid': '27893064', 'type': 'RESULT', 'citation': 'Maas C, Mathes M, Bleeker C, Vek J, Bernhard W, Wiechers C, Peter A, Poets CF, Franz AR. Effect of Increased Enteral Protein Intake on Growth in Human Milk-Fed Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2017 Jan 1;171(1):16-22. doi: 10.1001/jamapediatrics.2016.2681.'}, {'pmid': '29739389', 'type': 'DERIVED', 'citation': 'Mathes M, Maas C, Bleeker C, Vek J, Bernhard W, Peter A, Poets CF, Franz AR. Effect of increased enteral protein intake on plasma and urinary urea concentrations in preterm infants born at < 32 weeks gestation and < 1500 g birth weight enrolled in a randomized controlled trial - a secondary analysis. BMC Pediatr. 2018 May 8;18(1):154. doi: 10.1186/s12887-018-1136-5.'}, {'pmid': '27164830', 'type': 'DERIVED', 'citation': "Maas C, Franz AR, Shunova A, Mathes M, Bleeker C, Poets CF, Schleicher E, Bernhard W. Choline and polyunsaturated fatty acids in preterm infants' maternal milk. Eur J Nutr. 2017 Jun;56(4):1733-1742. doi: 10.1007/s00394-016-1220-2. Epub 2016 May 10."}]}, 'descriptionModule': {'briefSummary': 'Although expressed breast milk is considered the optimal nutritional source for preterm infants, the macronutrient content is insufficient to enable optimal growth during neonatal intensive care. Optimal dose and optimal mode of administration (standardized or individualized) of enteral protein supplementation to very preterm infants have not been established.\n\nThis study aims to compare the effects on weight gain of different modes of enteral protein supplementation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* very preterm infants \\<32 weeks gestation and \\<1500g birth weight\n* \\> 100ml/kg/d of enteral feeding\n\nExclusion Criteria:\n\n* missing informed consent\n* decision not to feed breast milk\n* congenital malformations\n* age \\> 7 days at study entry'}, 'identificationModule': {'nctId': 'NCT01773902', 'briefTitle': 'Protein for Premies', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'High Versus Standard Dose Protein for Very Preterm Infants', 'orgStudyIdInfo': {'id': 'PfP3.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Dose Protein (Individualized)', 'description': 'Protein supplementation according to breast milk content aiming for 4.5g/kg/d of enteral protein if \\<1500g b.w. or 4.0g/kg/d of enteral protein if \\>1500g b.w. until 1 week before discharge', 'interventionNames': ['Dietary Supplement: High Dose Protein (Individualized)']}, {'type': 'EXPERIMENTAL', 'label': 'High Dose Protein (Standardized)', 'description': 'Protein supplementation independent of individual breast milk content using a new high-dose-protein breast milk fortifier until 1 week before discharge', 'interventionNames': ['Dietary Supplement: High Dose Protein (Standardized)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard protein supplementation', 'description': 'Protein supplementation independent of individual breast milk content using a standard dose of a standard breast milk fortifier until 1 week before discharge', 'interventionNames': ['Dietary Supplement: Standard Protein Supplementation']}], 'interventions': [{'name': 'High Dose Protein (Individualized)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Protein supplementation according to breast milk content aiming for 4.5g/kg/d of enteral protein if \\<1500g b.w. or 4.0g/kg/d of enteral protein if \\>1500g b.w. until 1 week before discharge', 'armGroupLabels': ['High Dose Protein (Individualized)']}, {'name': 'High Dose Protein (Standardized)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Protein supplementation independent of individual breast milk content using a new high-dose-protein breast milk fortifier until 1 week before discharge', 'armGroupLabels': ['High Dose Protein (Standardized)']}, {'name': 'Standard Protein Supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Protein supplementation independent of individual breast milk content using a standard-dose-protein breast milk fortifier until 1 week before discharge', 'armGroupLabels': ['Standard protein supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': "University Children's Hospital Tuebingen", 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Axel Franz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universität Tübingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med.', 'investigatorFullName': 'Axel Franz', 'investigatorAffiliation': 'University Hospital Tuebingen'}}}}