Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT04584320
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-14
First Post:
2020-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Identification of Clostridium Butyricum and Clostridium Neonatal in the Digestive Microbiota of Premature Infants Before 34 Weeks and Developing or Not Ulcerative Necrotizing Enterocolitis (NEC) During Hospitalization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020345', 'term': 'Enterocolitis, Necrotizing'}], 'ancestors': [{'id': 'D004760', 'term': 'Enterocolitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Stool samples taken daily from nappies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-12', 'studyFirstSubmitDate': '2020-10-01', 'studyFirstSubmitQcDate': '2020-10-09', 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age of mother', 'timeFrame': 'Day 0', 'description': 'Years'}, {'measure': 'Body mass index of mother', 'timeFrame': 'Day 0', 'description': 'Kg/m2'}, {'measure': 'Parity of mother', 'timeFrame': 'Day 0'}, {'measure': 'Gravidity of mother', 'timeFrame': 'Day 0'}, {'measure': 'Professional activity of mother', 'timeFrame': 'Day 0', 'description': 'Yes/no; description'}, {'measure': 'Smoking status of mother', 'timeFrame': 'Day 0', 'description': 'Yes/no'}, {'measure': 'Chronic pathology of mother', 'timeFrame': 'Day 0', 'description': 'Yes/no, description'}, {'measure': 'Allergy of mother', 'timeFrame': 'Day 0', 'description': 'Yes/no, description'}, {'measure': 'Number of years of schooling of mother', 'timeFrame': 'Day 0'}, {'measure': 'Exposure to magnesium sulfate during pregnancy', 'timeFrame': 'Day 0', 'description': 'Yes/no'}, {'measure': 'Cause of prematurity', 'timeFrame': 'Day 0'}, {'measure': 'Method of delivery', 'timeFrame': 'Day 0', 'description': 'Vagina/Caesarean'}, {'measure': 'Anesthesia during delivery', 'timeFrame': 'Day 0', 'description': 'General/spinal'}, {'measure': 'Mode of delivery of vaginal birth', 'timeFrame': 'Day 0', 'description': 'Spontaneous/instrumental'}, {'measure': 'Spontaneous rupture of membranes', 'timeFrame': 'Day 0', 'description': 'Yes/no'}, {'measure': 'Time of rupture of membranes before birth', 'timeFrame': 'Day 0', 'description': '\\<12h/\\>12h'}, {'measure': 'Pathology during pregnancy', 'timeFrame': 'Day 0', 'description': 'Yes/No; description'}, {'measure': 'Birth term', 'timeFrame': 'Day 0', 'description': 'Weeks and days'}, {'measure': 'Birth weight', 'timeFrame': 'Day 0', 'description': 'grams'}, {'measure': 'Birth weight percentile', 'timeFrame': 'Day 0', 'description': 'percentile'}, {'measure': 'Birth height', 'timeFrame': 'Day 0', 'description': 'cm'}, {'measure': 'Birth height ; percentile', 'timeFrame': 'Day 0', 'description': 'percentile'}, {'measure': 'Intubation', 'timeFrame': 'Day 0', 'description': 'Yes/no'}, {'measure': 'umbilical venous catheter', 'timeFrame': 'Day 0', 'description': 'Yes/no; duration'}, {'measure': 'Epicutaneo-cava catheter', 'timeFrame': 'Day 0', 'description': 'Yes/no; duration'}, {'measure': 'Daily lipid intake per os per kilp', 'timeFrame': 'During hospitlization (maximum 120 days)', 'description': 'g/kg'}, {'measure': 'Presence of sequelae', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Yes/no'}, {'measure': 'Type of sequelae', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'description'}, {'measure': 'Hemodynamically significant patent ductus arteriosus', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Yes/no'}, {'measure': 'Type of milk', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'pasteurized/fresh/artificial'}, {'measure': 'Duration of milk intake', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Days'}, {'measure': 'Probiotic intake duration', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Days'}, {'measure': 'Types of probiotic taken', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Type'}, {'measure': 'Type of antibiotics taken in post-natal period', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Type'}, {'measure': 'Duration of antibiotic treatment in post-natal period', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Days'}, {'measure': 'Type of vasoactive amines taken', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Type'}, {'measure': 'Duration of vasoactive amine treatment', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Days'}, {'measure': 'Type of any postnatal surgery', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Type'}, {'measure': 'Total duration of parenteral feeding', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Days'}, {'measure': 'Ibuprofen', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Yes/no'}, {'measure': 'Hemodynamic shock', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Yes/no'}, {'measure': 'Labile Blood Product transfusion', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Amount'}, {'measure': 'antenatal corticosteroid therapy', 'timeFrame': 'Day 0', 'description': 'Complete/incomplete'}, {'measure': 'Type of post-natal corticosteroid therapy', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Type'}, {'measure': 'Duration of post-natal corticosteroid therapy', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Days'}, {'measure': 'Exposure to ante- and post-natal antibiotics', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Description'}, {'measure': 'umbilical arterial catheter', 'timeFrame': 'Day 0', 'description': 'Duration'}, {'measure': 'Nosocomial infection', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Proven/suspected'}, {'measure': 'Nosocomial infection infective agent', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'name'}, {'measure': 'Rectal bleeding', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Number'}, {'measure': 'metabolic acidosis', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Yes/no'}, {'measure': 'Volume of alimentation per kilo', 'timeFrame': 'During hospitalization (maximum 120 days)'}, {'measure': 'Daily carbohydrate intake per os per kilp', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'g/kg'}, {'measure': 'Daily proteins intake per os per kilp', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'g/kg'}, {'measure': 'Volume of daily total alimentation', 'timeFrame': 'During hospitalization (maximum 120 days)'}, {'measure': 'Cranial circumference', 'timeFrame': 'Day 0', 'description': 'cm; percentile'}, {'measure': 'Cranial circumference percentile', 'timeFrame': 'Day 0', 'description': 'percentile'}, {'measure': 'Other catheter', 'timeFrame': 'Day 0', 'description': 'Type'}, {'measure': 'Duration of other catheter', 'timeFrame': 'Day 0', 'description': 'Days'}, {'measure': 'Enriched maternal milk', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Maximum percentage'}, {'measure': 'Milk thickening', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Duration'}, {'measure': 'Chorioamnionitis', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Proven/suspected'}, {'measure': 'Materno-fetal infection', 'timeFrame': 'Day 0', 'description': 'Proven/suspected'}, {'measure': 'Materno-fetal infection infective agent', 'timeFrame': 'Day 0', 'description': 'name'}, {'measure': 'pneumatosis-pneumoportia', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Yes/no'}, {'measure': 'Transfer', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Yes/no'}, {'measure': 'Time of occurence of ulcerative necrotizing enterocolitis', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'weeks post-natal'}, {'measure': 'Warning signs of ulcerative necrotizing enterocolitis', 'timeFrame': 'During hospitalization (maximum 120 days)'}, {'measure': 'Duration of bowel rest following necrotizing enterocolitis', 'timeFrame': 'During hospitalization (maximum 120 days)'}, {'measure': 'Bell staging of ulcerative necrotizing enterocolitis', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'from IA (suspected necrotizing enterocolitis) to IIIB (advanced necrotizing enterocolitis)'}], 'primaryOutcomes': [{'measure': 'Presence of C. butyricum', 'timeFrame': 'Each day of hospitalization (maximum 120 days)', 'description': 'PCR'}, {'measure': 'Presence of C. neonatale', 'timeFrame': 'Each day of hospitalization (maximum 120 days)', 'description': 'PCR'}, {'measure': 'Culture of C. butyricum', 'timeFrame': 'Each day of hospitalization (maximum 120 days)', 'description': 'Growth on selective media'}, {'measure': 'Culture of C. neonatale', 'timeFrame': 'Each day of hospitalization (maximum 120 days)', 'description': 'Growth on selective media'}], 'secondaryOutcomes': [{'measure': 'Localisation within the hospital', 'timeFrame': 'During hospitalization (maximum 120 days)', 'description': 'Bed numbers occupied'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['low-birth weight infant', 'Clostridium butyricum', 'Clostridium neonatale'], 'conditions': ['Necrotizing Enterocolitis']}, 'descriptionModule': {'briefSummary': 'The study investigators hypothesize that Clostridium butyricum and Clostridium neonatal will be more frequently found in the stool of preterm infants with ulcerative necrotizing enterocolitis compared to healthy matched control infants. Systematic daily samples should show that the kinetics of colonization precedes the onset of the pathology. Finally, the systematic ecological survey at the time of infection could help understand the mode of acquisition and transmission of these bacteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of all newborns born less than 34 weeks of gestation admitted to the neonatology department of the CHU de Nîmes.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Premature newborn with a term of birth ≤ 34 weeks of gestation admitted to the neonatology department at the CHU of Nîmes.\n* Affiliated or beneficiary of a health insurance plan.\n* Newborn whose parents received informed information about the study and did not express their opposition to their child's participation in the study.\n\nExclusion Criteria:\n\n* Newborn with malformative digestive pathology\n* Newborn baby participating in another category 1 trial"}, 'identificationModule': {'nctId': 'NCT04584320', 'acronym': 'ECUN-2', 'briefTitle': 'Identification of Clostridium Butyricum and Clostridium Neonatal in the Digestive Microbiota of Premature Infants Before 34 Weeks and Developing or Not Ulcerative Necrotizing Enterocolitis (NEC) During Hospitalization', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Qualitative and Quantitative Identification of Clostridium Butyricum and Clostridium Neonatal in the Digestive Microbiota of Premature Infants Before 34 Weeks and Developing or Not Ulcerative Necrotizing Enterocolitis (NEC) During Their Hospitalization in Neonatology', 'orgStudyIdInfo': {'id': 'NIMAO/2019-01/MdM01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Premature neonates with necrotizing enterocolitis', 'interventionNames': ['Other: Stool sample']}, {'label': 'Premature neonates without necrotizing enterocolitis', 'interventionNames': ['Other: Stool sample']}], 'interventions': [{'name': 'Stool sample', 'type': 'OTHER', 'description': 'Stools samples taken daily to test for present of Clostridium butyricum and Clostridium neonatale', 'armGroupLabels': ['Premature neonates with necrotizing enterocolitis', 'Premature neonates without necrotizing enterocolitis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Massimo De Maio', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Nimes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}