NCT04972734

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 1 Minute – 2 Minutes
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Monitoring of a cohort of premature newborns with constitution of a collection of biological samples. follow-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. * Sampling of amniotic fluid at the time of rupture of the water bag * Sampling of the blood contained in the umbilical cord after clamping and section of the cord * Sampling of meconium during the first 24 hours of life in intensive care / neonatal / maternity ward * Collection of a daily stool sample until the end of hospitalization and when a NEC occurs * Sampling of gastric residues during an episode of NEC * Taking a daily sample of the newborn's enteral food * Sampling of 500 µL of additional blood weekly during the punctures made for the treatment * Daily statement of constants * Record of all complications related to prematurity (HIV, bronchodysplastic, sepsis) * 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) * Analysis of the meconium sample and each stool emitted during hospitalization, and during an episode of ECUN

Conditions

• Necrotizing Enterocolitis
• Premature Birth

Interventions

Type	Name	Description
BIOLOGICAL	premature newborns developing a NEC	weekly Blood sample and daily Stools sample during 12 weeks + Blood and stool sample during NEC
BIOLOGICAL	premature newborns without NEC	weekly Blood sample and daily Stools sample during 12 weeks

Timeline

• Start date: 2021-07-02
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2021-07-22
• Last updated: 2024-01-29

Locations

1 site across 1 country: France