Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2026-02-26 @ 3:17 AM
Study NCT ID:
NCT02502916
Status:
COMPLETED
Last Update Posted:
2015-07-20
First Post:
2015-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enteral Feeding and Early Gut Colonization of Preterm 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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "meconium, fecal samples mother's milk donor's milk"}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-16', 'studyFirstSubmitDate': '2015-07-12', 'studyFirstSubmitQcDate': '2015-07-16', 'lastUpdatePostDateStruct': {'date': '2015-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of infants sharing bacterial strains with the milk received by each one', 'timeFrame': 'two years', 'description': "The meconium and fecal samples of the infants have been analysed microbiologically. In parallel, own's mother milk, donor milk and formula milk have been analyzed microbiologically after their pass through the nasogastric feeding tube. The bacterial strains isolated from fecal samples of each infant have been compared with the bacterial strains isolated from the milk that have received each of them."}], 'secondaryOutcomes': [{'measure': 'Number of bacterial strains shared by each infant and the milk received.', 'timeFrame': 'two years', 'description': 'In each infant the number of the same bacterial strains isolated from fecal samples and milk received have been determined.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Premature Birth of Newborn']}, 'referencesModule': {'references': [{'pmid': '26741949', 'type': 'DERIVED', 'citation': 'Gomez M, Moles L, Melgar A, Ureta N, Bustos G, Fernandez L, Rodriguez JM, Jimenez E. Early Gut Colonization of Preterm Infants: Effect of Enteral Feeding Tubes. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):893-900. doi: 10.1097/MPG.0000000000001104.'}]}, 'descriptionModule': {'briefSummary': "The aim of this study is to evaluate the potential role of the enteral feeding systems on the bacterial colonization of premature infants during their NICU admittance and its evolution after 2 years, which is the age when the infant's gut starts to contain an adult-like microbiota.", 'detailedDescription': "First spontaneously evacuated meconium and fecal samples were collected by the medical staff of the Hospital weekly from the diapers of the infants during their stay at the Neonatal Intensive Care Unit.\n\nTo evaluate the potential role of the enteral feeding systems as a site for colonization by nosocomial bacteria, and, its impact on early gut colonization of preterm neonates, mother's own milk, donor milk and preterm formula samples were obtained after passing through the external part of the enteral feeding tubes and cultured.\n\nLater, when the infants reached 2 years of age, parents were contacted by phone to provide an additional fecal sample if their infants had not taken antibiotics within the previous 2 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Hours', 'minimumAge': '2 Hours', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm infants born from October 2009 to June 2010 at the Hospital 12 de Octubre with a gestational age of less than 32 weeks or with birth weight of less than 1,200 g', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gestational age of less than 32 weeks or with birth weight of less than 1,200 g\n\nExclusion Criteria:\n\n* any malformation or suffering from any genetic metabolic disorder'}, 'identificationModule': {'nctId': 'NCT02502916', 'acronym': 'PRECOL', 'briefTitle': 'Enteral Feeding and Early Gut Colonization of Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Complutense de Madrid'}, 'officialTitle': 'Potential Role of the Enteral Feeding Systems on Early Bacterial Gut Colonization of Preterm Infants', 'orgStudyIdInfo': {'id': 'PROBILAC/12O_2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preterm infant', 'description': 'Preterm infants born from October 2009 to June 2010 at a gestational age of less than 32 weeks or with birth weight of less than 1,200 g'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Juan M Rodriguez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Complutense Madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Juan M. RodrÃguez', 'investigatorAffiliation': 'Universidad Complutense de Madrid'}}}}