Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-28 @ 12:08 PM
Study NCT ID:
NCT00213668
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005973', 'term': 'Glutamine'}, {'id': 'C054122', 'term': 'alanylglutamine'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'lastUpdateSubmitDate': '2013-06-17', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gastric emptying', 'timeFrame': 'at day 0, day 1, day 7 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product'}], 'secondaryOutcomes': [{'measure': 'intestinal transit', 'timeFrame': 'at day 1 and day 14 of enteral nutrition enriched by glutamine or isonitrogenous product'}, {'measure': 'date and duration of arrest of nutrition if necessary'}, {'measure': 'age of total enteral nutrition'}, {'measure': 'age at the end of hospitalization'}, {'measure': 'variation of cholescystokinin and gastrin postprandial concentration', 'timeFrame': 'at day 0 and day 14'}]}, 'conditionsModule': {'keywords': ['glutamine', 'premature neonate', 'gastric emptying'], 'conditions': ['Enteral Feeding']}, 'descriptionModule': {'briefSummary': 'This study investigates the effects of enterally supplied glutamine on gastric emptying, intestinal transit, age of total enteral nutrition and age at the end of hospitalisation. Forty neonates, aged at least 2 days and free of acute illness participate in a prospective, randomised, double-blind study. All are fed with parenteral and enteral nutrition enriched with glutamine (0.7 g/kg/per day, group 1) or isonitrogenous control (group 2). Gastric emptying is analysed by sequential measure of intragastric residue by diluted polyethylene glycol (PEG) 4000. Intestinal transit is analysed by Rouge Carmin test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Days', 'minimumAge': '2 Days', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premature neonates aged 30-33 weeks of gestational age\n* Aged at least 2 days and no more than 10 days\n* Free of acute illness\n* Written informed consent is obtained from the parent prior to enrolment.\n\nExclusion Criteria:\n\n* Premature infants with respiratory (fraction of inspired oxygen \\[FiO2\\] \\> 30%), or cardiovascular, liver, intestinal or acute diseases\n* Premature infants with congenital syndrome'}, 'identificationModule': {'nctId': 'NCT00213668', 'briefTitle': 'Effect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Effect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates', 'orgStudyIdInfo': {'id': '2000/111/HP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'glutamine (dipeptiven)', 'type': 'DIETARY_SUPPLEMENT'}]}, 'contactsLocationsModule': {'locations': [{'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'CHU-Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'Anne Mercier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Rouen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}