Characterizing digestive microbiota in premature newborns with necrotizing enterocolitis
Cohort of Premature Newborns for Charaterization of the Digestive Microbiota in Ulcerative Necrotizing Enterocolitis in Premature Infants
This study looks at the gut bacteria of premature newborns to see if there are differences between those who develop necrotizing enterocolitis and those who don’t.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 1 Minute to 2 Minutes |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT04972734 on ClinicalTrials.gov |
What this trial studies
This study monitors a cohort of premature newborns to compare the digestive microbiota between those developing necrotizing enterocolitis (NEC) and those who do not. It involves the collection of various biological samples, including amniotic fluid, umbilical cord blood, meconium, stool, and enteral food, throughout the newborns' stay in the neonatal intensive care unit. The research aims to analyze these samples for specific biomarkers and microbiological signatures associated with NEC. The medical care provided to the newborns will remain unaffected by their participation in the study.
Who should consider this trial
Good fit: Ideal candidates are premature newborns born before 37 weeks of amenorrhea at the CHU Clermont-Ferrand maternity ward.
Not a fit: Patients with fetal pathology or whose guardians are unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of necrotizing enterocolitis in premature infants.
How similar studies have performed: While studies on microbiota in NEC exist, this specific approach focusing on a cohort of premature infants is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Clermont-Ferrand
- CHU Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
Study contacts
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 04 73 75 11 95
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.