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

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

Recruiting
2 years and younger
All
Phase N/A

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Overview

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.

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

Eligibility

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

Study details
    Necrotizing Enterocolitis
    Premature Birth

NCT04972734

University Hospital, Clermont-Ferrand

18 February 2024

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