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Search / Trial NCT04972734

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

Launched by UNIVERSITY HOSPITAL, CLERMONT-FERRAND · Jul 12, 2021

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Necrotizing Enterocolitis Prematurity Volatolomic And Microbiological Signatures Mast Cell Activation Blood Tryptase Assay Fungal Digestive Colonization Fecal Calprotectin

ClinConnect Summary

This clinical trial is studying the differences in gut bacteria between premature newborns who develop a serious condition called necrotizing enterocolitis (NEC) and those who do not. NEC is a condition that affects the intestines of premature babies, and researchers want to understand how the bacteria in their digestive systems might be involved. By comparing these two groups of babies while they are in the neonatal intensive care unit (NICU), the study aims to gather important information that could help improve treatment and outcomes for premature infants.

To be eligible for this study, babies must be born prematurely, meaning before 37 weeks of pregnancy, and must be receiving care at the designated hospital. Parents or guardians must also be able to give informed consent for their baby's participation. If you choose to participate, your baby will be monitored during their time in the NICU, and samples will be collected to study the gut bacteria. This research is important as it may lead to better understanding and management of NEC, ultimately helping to protect the health of future premature infants.

Gender

ALL

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

About University Hospital, Clermont Ferrand

The University Hospital of Clermont-Ferrand is a leading academic medical institution dedicated to advancing healthcare through innovative research and clinical trials. Renowned for its multidisciplinary approach, the hospital integrates cutting-edge scientific inquiry with patient care, fostering an environment that promotes collaboration among healthcare professionals, researchers, and academic partners. With a strong commitment to improving patient outcomes, the institution actively engages in a wide array of clinical studies, ranging from early-phase trials to large-scale interventions, aimed at addressing critical health challenges and enhancing treatment modalities. Its state-of-the-art facilities and expertise make it a pivotal contributor to clinical research in the region and beyond.

Locations

Clermont Ferrand, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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