Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-26 @ 4:07 PM
Study NCT ID:
NCT04972734
Status:
RECRUITING
Last Update Posted:
2024-01-29
First Post:
2021-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort of Premature Newborns for Charaterization of the Digestive Microbiota in Ulcerative Necrotizing Enterocolitis in Premature Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020345', 'term': 'Enterocolitis, Necrotizing'}, {'id': 'D047928', 'term': 'Premature Birth'}], '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'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-26', 'studyFirstSubmitDate': '2021-06-28', 'studyFirstSubmitQcDate': '2021-07-12', 'lastUpdatePostDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison of volatolomics results of the gut microbiota', 'timeFrame': 'Immediatly after the intervention', 'description': 'Characterization of the gut microbiota using a capture method by hybridization of the gene encoding 16S rRNA'}, {'measure': 'comparison of microbiological results of the gut microbiota', 'timeFrame': 'Immediatly after the intervention', 'description': 'Characterization of the gut microbiota using a capture method by hybridization of the gene encoding 16S rRNA'}], 'secondaryOutcomes': [{'measure': 'Fungal microbiota', 'timeFrame': 'Immediatly after the intervention', 'description': 'Comparison of the fungal microbiota on 10 NECS and 10 healthy babies'}, {'measure': 'Tryptasemia', 'timeFrame': 'Day 1, Day 3, Immediatly after the intervention', 'description': 'measurement of blood tryptasemia'}, {'measure': 'environmental xenobiotics', 'timeFrame': 'Day 1', 'description': 'measurement of titane and silicia levels in placental and meconium assays'}, {'measure': 'Milk protein composition', 'timeFrame': 'daily for 12 weekd', 'description': 'milk protein determination'}, {'measure': 'Milk lipid composition', 'timeFrame': 'daily for 12 weekd', 'description': 'milk lipid determination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Necrotizing Enterocolitis', 'prematurity', 'volatolomic and microbiological signatures', 'mast cell activation', 'blood tryptase assay', 'fungal digestive colonization', 'fecal calprotectin'], 'conditions': ['Necrotizing Enterocolitis', 'Premature Birth']}, 'descriptionModule': {'briefSummary': 'Compare the bacterial digestive microbiota during the stay in neonatal intensive care between a group of premature newborns developing a NEC (necrotizing enterocolitis) and a group of newborns free from NEC.', 'detailedDescription': "Monitoring of a cohort of premature newborns with constitution of a collection of biological samples.\n\nfollow-up of newborns from birth up to 37 weeks of amenorrhea. The medical care of children will not be affected by their participation in the research.\n\n* Sampling of amniotic fluid at the time of rupture of the water bag\n* Sampling of the blood contained in the umbilical cord after clamping and section of the cord\n* Sampling of meconium during the first 24 hours of life in intensive care / neonatal / maternity ward\n* Collection of a daily stool sample until the end of hospitalization and when a NEC occurs\n* Sampling of gastric residues during an episode of NEC\n* Taking a daily sample of the newborn's enteral food\n* Sampling of 500 µL of additional blood weekly during the punctures made for the treatment\n* Daily statement of constants\n* Record of all complications related to prematurity (HIV, bronchodysplastic, sepsis)\n\n * Blood analysis: CBC, platelets and CRP (data analyzed as part of the treatment). Specific analyzes for research will assess: the level of tryptase, IL4 and TLR4. The samples will be stored and analyzed in the immunology laboratory of the CHU Clermont Ferrand (Pr B. Evrard)\n * Analysis of the meconium sample and each stool emitted during hospitalization, and during an episode of ECUN"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Minutes', 'minimumAge': '1 Minute', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* born prematurely \\< 37 weeks of amenorrhea at the maternity ward of the CHU\n* affiliated with a social security regime\n* the holders of parental authority are able to give an informed consent to participate in the research\n\nExclusion Criteria:\n\n* fetal pathology\n* newborns whose holders of parental authority are under guardianship or under the age of 18\n* refusal of participation by holders of parental authority'}, 'identificationModule': {'nctId': 'NCT04972734', 'acronym': 'CortECS', 'briefTitle': 'Cohort of Premature Newborns for Charaterization of the Digestive Microbiota in Ulcerative Necrotizing Enterocolitis in Premature Infants', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Cohort of Premature Newborns for Charaterization of the Digestive Microbiota in Ulcerative Necrotizing Enterocolitis in Premature Infants', 'orgStudyIdInfo': {'id': 'RBHP 2021 PONS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NEC', 'description': 'premature newborns developing a NEC', 'interventionNames': ['Biological: premature newborns developing a NEC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy control', 'description': 'premature newborns without NEC', 'interventionNames': ['Biological: premature newborns without NEC']}], 'interventions': [{'name': 'premature newborns developing a NEC', 'type': 'BIOLOGICAL', 'description': 'weekly Blood sample and daily Stools sample during 12 weeks + Blood and stool sample during NEC', 'armGroupLabels': ['NEC']}, {'name': 'premature newborns without NEC', 'type': 'BIOLOGICAL', 'description': 'weekly Blood sample and daily Stools sample during 12 weeks', 'armGroupLabels': ['Healthy control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lise Laclautre', 'role': 'CONTACT', 'email': 'promo_interne_drci@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}, {'name': 'Maguelonne PONS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Lise Laclautre', 'role': 'CONTACT', 'email': 'promo_interne_drci@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'MEDIS Laboratory', 'class': 'UNKNOWN'}, {'name': 'QUAPA', 'class': 'UNKNOWN'}, {'name': 'ENTeRisk', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}