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Clinical trial

Cohort of Premature Newborns for Charaterization of the Digestive Microbiota in Ulcerative Necrotizing Enterocolitis in Premature Infants

ID
Name
RBHP 2021 PONS
Description
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.
Trial arms
Trial start
2021-07-02
Estimated PCD
2025-01-01
Trial end
2025-01-01
Status
Recruiting
Treatment
premature newborns developing a NEC
weekly Blood sample and daily Stools sample during 12 weeks + Blood and stool sample during NEC
Arms:
NEC
premature newborns without NEC
weekly Blood sample and daily Stools sample during 12 weeks
Arms:
Healthy control
Size
400
Primary endpoint
comparison of volatolomics results of the gut microbiota
Immediatly after the intervention
comparison of microbiological results of the gut microbiota
Immediatly after the intervention
Eligibility criteria
Inclusion Criteria: * born prematurely \< 37 weeks of amenorrhea at the maternity ward of the CHU * affiliated with a social security regime * the holders of parental authority are able to give an informed consent to participate in the research Exclusion Criteria: * fetal pathology * newborns whose holders of parental authority are under guardianship or under the age of 18 * refusal of participation by holders of parental authority
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 400, 'type': 'ESTIMATED'}}
Updated at
2024-01-29

1 organization

2 products

2 indications

Organization
University Hospital Clermont-Ferrand
Product
Premature newborns developing a NEC
Indication
Necrotizing enterocolitis
Indication
Preterm Birth
Product
Premature Newborns