Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT01609868
Status:
COMPLETED
Last Update Posted:
2018-01-31
First Post:
2012-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of a Liquid Protein Modular on Growth and Outcomes in the NICU
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': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-29', 'studyFirstSubmitDate': '2012-05-30', 'studyFirstSubmitQcDate': '2012-05-31', 'lastUpdatePostDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Growth in premature infants (percentile ranking at 36 weeks CGA)', 'timeFrame': 'birth to 36 weeks'}], 'secondaryOutcomes': [{'measure': 'GI tolerance', 'timeFrame': 'birth to 36 weeks', 'description': 'abdominal distention, feeding tolerance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['premature infant feeding protein'], 'conditions': ['Problem With Growth of an Infant']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesis that premature infants receiving a commercially available liquid protein modular will have improved growth when compared with premature infants receiving a commercially available powder protein modular.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '40 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants less than 2000 gms at birth, receiving maternal breast milk\n\nExclusion Criteria:\n\n* Infants receiving formula'}, 'identificationModule': {'nctId': 'NCT01609868', 'briefTitle': 'The Effect of a Liquid Protein Modular on Growth and Outcomes in the NICU', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'The Effect of a Liquid Protein Modular on Growth and Outcomes in the NICU', 'orgStudyIdInfo': {'id': '12-16432'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'infants in this arm will receive the current treatment that is standard of care for these infants, powder protein modular to achieve 4 gm/kg/day', 'interventionNames': ['Dietary Supplement: Powder protein modular']}, {'type': 'EXPERIMENTAL', 'label': 'experimental', 'description': 'this group will receive a liquid protein modular that recently became commercially avaliable, to achieve the same protein of 4 grm/kg/day as the powder comparision group', 'interventionNames': ['Dietary Supplement: Liquid protein modular']}], 'interventions': [{'name': 'Powder protein modular', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Infants will receive powder protein modular to achieve 4 grm/kg/day', 'armGroupLabels': ['control']}, {'name': 'Liquid protein modular', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Infants will receive a commerically avaliable liquid protein modular to provide 4 grm/kg/day', 'armGroupLabels': ['experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Alegent Bergan Hospital', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alegent Health Bergan Mercy Medical Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'IRB Administrator', 'investigatorFullName': 'Corrine K. Hanson, PhD', 'investigatorAffiliation': 'University of Nebraska'}}}}