Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-04 @ 5:00 PM
Study NCT ID:
NCT01965769
Status:
COMPLETED
Last Update Posted:
2013-10-18
First Post:
2013-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects Of Not Measuring Gastric Residual Content On Feeding Tolerance In Premature Infants 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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-15', 'studyFirstSubmitDate': '2013-10-15', 'studyFirstSubmitQcDate': '2013-10-15', 'lastUpdatePostDateStruct': {'date': '2013-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of feeding intake at 2 weeks', 'timeFrame': 'Baseline to 2 weeks'}], 'secondaryOutcomes': [{'measure': 'Days to 120 mL/kg/d of enteral feedings', 'timeFrame': 'Baseline to approximately 21 days'}, {'measure': 'Days of parenteral nutrition', 'timeFrame': 'Baseline to approximately 21 days'}, {'measure': 'Incidence of late onset sepsis', 'timeFrame': 'Baseline to approximately 90 days'}, {'measure': 'Weekly or biweekly liver function tests', 'timeFrame': 'Baseline to 42 days', 'description': 'Direct bilirubin'}, {'measure': 'Growth indices', 'timeFrame': 'Baseline to approximately 90 days', 'description': 'Weight, length and head circumference'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Baseline to approximately 90 days'}, {'measure': 'Incidence of necrotizing enterocolitis', 'timeFrame': 'Baseline to approximately 90 days'}, {'measure': 'Days requiring a central venous line', 'timeFrame': 'Baseline to approximately 21 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Very low birth weight infants', 'premature', 'nutrition', 'gastric residual'], 'conditions': ['Premature Infant']}, 'descriptionModule': {'briefSummary': 'Omitting evaluation of gastric residual contents prior to feeding very premature infants will increase the feeding intake at 2 weeks, and total caloric intake and growth by 3 weeks, as well as decrease the time required for parenteral nutrition.', 'detailedDescription': 'Infants were randomized into 2 groups. Group 1 had no gastric residuals evaluated prior to feeding. Group 2 had gastric residuals evaluated prior to feeding. Nutritional outcomes were compared between groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age less than 32 weeks,\n* Birth weight less than or equal to 1250 grams,\n* Initial feeding tolerated within 48 hours of life\n\nExclusion Criteria:\n\n* Congenital or chromosomal disorders,\n* Severe complications leading to death in the first week of life'}, 'identificationModule': {'nctId': 'NCT01965769', 'briefTitle': 'Effects Of Not Measuring Gastric Residual Content On Feeding Tolerance In Premature Infants iNFANTS', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Effects Of Not Measuring Gastric Residuals Prior To Enteral Bolus Feeding On Gastrointestinal Function And Feeding Tolerance In Very Low Birth Weight Infants', 'orgStudyIdInfo': {'id': '2011-216'}, 'secondaryIdInfos': [{'id': 'Gerber003', 'type': 'OTHER', 'domain': 'Gerber'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'no gastric residual evaluation', 'description': 'Infants will not receive routine gastric residual evaluation prior to feeding', 'interventionNames': ['Other: No gastric residual evaluation']}, {'type': 'NO_INTERVENTION', 'label': 'gastric residual evaluation', 'description': 'Infants will receive routine gastric residual evaluation'}], 'interventions': [{'name': 'No gastric residual evaluation', 'type': 'OTHER', 'description': 'Infants will not receive routine gastric residual evaluation prior to feeding.', 'armGroupLabels': ['no gastric residual evaluation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF & Shands Hospital', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Josef Neu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Gerber Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}