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Identification of Clostridium Butyricum and Clostridium Neonatal in the Digestive Microbiota of Premature Infants Before 34 Weeks and Developing or Not Ulcerative Necrotizing Enterocolitis (NEC) During Hospitalization (ECUN-2)

C

Centre Hospitalier Universitaire de Nīmes

Status

Active, not recruiting

Conditions

Necrotizing Enterocolitis

Treatments

Other: Stool sample

Study type

Observational

Funder types

Other

Identifiers

NCT04584320
NIMAO/2019-01/MdM01

Details and patient eligibility

About

The study investigators hypothesize that Clostridium butyricum and Clostridium neonatal will be more frequently found in the stool of preterm infants with ulcerative necrotizing enterocolitis compared to healthy matched control infants. Systematic daily samples should show that the kinetics of colonization precedes the onset of the pathology. Finally, the systematic ecological survey at the time of infection could help understand the mode of acquisition and transmission of these bacteria.

Enrollment

40 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Premature newborn with a term of birth ≤ 34 weeks of gestation admitted to the neonatology department at the CHU of Nîmes.
  • Affiliated or beneficiary of a health insurance plan.
  • Newborn whose parents received informed information about the study and did not express their opposition to their child's participation in the study.

Exclusion criteria

  • Newborn with malformative digestive pathology
  • Newborn baby participating in another category 1 trial

Trial design

40 participants in 2 patient groups

Premature neonates with necrotizing enterocolitis
Treatment:
Other: Stool sample
Premature neonates without necrotizing enterocolitis
Treatment:
Other: Stool sample

Trial contacts and locations

1

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Central trial contact

Massimo De Maio

Data sourced from clinicaltrials.gov

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