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

Study Overview
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Brief Summary
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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.

Official Title
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Qualitative and Quantitative 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 Their Hospitalization in Neonatology

Conditions
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Necrotizing Enterocolitis

Intervention / Treatment
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* Other: Stool sample


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Premature neonates with necrotizing enterocolitis<br> | Other: Stool sample<br>* Stools samples taken daily to test for present of Clostridium butyricum and Clostridium neonatale<br>|
| Premature neonates without necrotizing enterocolitis<br> | Other: Stool sample<br>* Stools samples taken daily to test for present of Clostridium butyricum and Clostridium neonatale<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of C. butyricum | PCR | Each day of hospitalization (maximum 120 days) | 
| Presence of C. neonatale | PCR | Each day of hospitalization (maximum 120 days) | 
| Culture of C. butyricum | Growth on selective media | Each day of hospitalization (maximum 120 days) | 
| Culture of C. neonatale | Growth on selective media | Each day of hospitalization (maximum 120 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Localisation within the hospital | Bed numbers occupied | During hospitalization (maximum 120 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low-birth weight infant, Clostridium butyricum, Clostridium neonatale