Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT04792918
Status:
COMPLETED
Last Update Posted:
2023-07-10
First Post:
2021-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characterization of Intestinal Microbiota Stability in Preterm Born Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020345', 'term': 'Enterocolitis, Necrotizing'}, {'id': 'D000071074', 'term': 'Neonatal Sepsis'}], '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': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}, 'targetDuration': '4 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-07', 'studyFirstSubmitDate': '2021-03-09', 'studyFirstSubmitQcDate': '2021-03-09', 'lastUpdatePostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Strain-level stability', 'timeFrame': '24 months', 'description': 'Identify members of the gastrointestinal microbiota (species/strains) that are associated with development of NEC or LOS in very-low birthweight/very preterm Identify members of the gastrointestinal microbiota (species/strains) that are associated with development of NEC or LOS in very-low birthweight/very preterm infants via changes in frequencies, absolute colonization levels, or temporal stability'}], 'secondaryOutcomes': [{'measure': 'Source of bacterial species/strains', 'timeFrame': '24 months', 'description': 'Quantify genetic similarity between potentially disease-causing microbiota strains found within NEC/LOS patients and within family members (faeces, breastmilk, vaginal swab) and hospital surroundings'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Necrotising Enterocolitis', 'Late-Onset Neonatal Sepsis']}, 'descriptionModule': {'briefSummary': 'Study around very-low birthweight preterm infants at high risk of developing necrotizing enterocolitis (NEC) or late-onset sepsis (LOS). Collection of stool and other biological samples to assess the strain-level stability of gastrointestinal microbiota in these preterm infants who may or may not develop NEC/LOS.', 'detailedDescription': "This study aims to collect biological samples (stool, stomach fluid, and blood) from preterm infants at risk of developing NEC or LOS; as well as environmental samples from infants' hospital surroundings (swabs, air), nutritional intake (formula, breastmilk) and samples from their family members (faeces, vaginal swab).\n\nThe main focus of the study is to assess strain-level stability of gastrointestinal microbiota in these infants and potentially assess the source of disease-causing microbiota species/strains."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Days', 'minimumAge': '0 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is represented by infants born at gestational age below 32 weeks (very preterm born infants) or with a birthweight below 1500g (very low birthweight infants). It is estimated that approximately 100 infants will be enrolled during the study period. As the aim is to study stability of the premature microbiota within individual patients, the study design precludes the need of control groups.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Preterm infants with a gestational age \\< 32 weeks or a birthweight \\< 1500g and their family members\n\nExclusion Criteria:\n\n* Intestinal atresia\n* Live born infants referred to from other hospitals later than 3 days after birth'}, 'identificationModule': {'nctId': 'NCT04792918', 'acronym': 'NEC', 'briefTitle': 'Characterization of Intestinal Microbiota Stability in Preterm Born Neonates', 'organization': {'class': 'OTHER', 'fullName': 'ETH Zurich'}, 'officialTitle': 'Intestinal Microbiome Strain-level Stability in NEC/ or LOS Patients', 'orgStudyIdInfo': {'id': 'NEC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NEC/LOS preterm infants', 'description': 'Collection of biological samples (stool, stomach fluid, blood) and health-related data over the first few weeks of life, additional stool samples after onset of NEC/LOS'}, {'label': 'Preterm infants not developing NEC/LOS', 'description': 'Collection of biological samples (stool, stomach fluid, blood) and health-related data over the first few weeks of life'}, {'label': 'Family members of preterm infants', 'description': 'Collection of biological samples (stool, breastmilk, vaginal swab) and health-related data at one timepoint after the birth of the preterm infant from members of the family (mother, father)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8032', 'city': 'Zurich', 'country': 'Switzerland', 'facility': "University Children's Hospital Zürich", 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emma Marie Caroline Slack', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Zurich', 'class': 'OTHER'}, {'name': "University Children's Hospital, Zurich", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Emma Marie Caroline Slack', 'investigatorAffiliation': 'ETH Zurich'}}}}