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
Active, not recruiting
- Conditions
- Necrotizing Enterocolitis
- Registration Number
- NCT04584320
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Presence of C. butyricum Each day of hospitalization (maximum 120 days) PCR
Culture of C. butyricum Each day of hospitalization (maximum 120 days) Growth on selective media
Presence of C. neonatale Each day of hospitalization (maximum 120 days) PCR
Culture of C. neonatale Each day of hospitalization (maximum 120 days) Growth on selective media
- Secondary Outcome Measures
Name Time Method Localisation within the hospital During hospitalization (maximum 120 days) Bed numbers occupied
Trial Locations
- Locations (1)
CHU de Nimes
🇫🇷Nîmes, France
CHU de Nimes🇫🇷Nîmes, France