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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Necrotizing Enterocolitis, Premature Birth

Intervention / Treatment
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* Biological: premature newborns developing a NEC
* Biological: premature newborns without NEC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 2 Minutes

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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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NEC<br>premature newborns developing a NEC | Biological: premature newborns developing a NEC<br>* weekly Blood sample and daily Stools sample during 12 weeks + Blood and stool sample during NEC<br>|
| Active Comparator: Healthy control<br>premature newborns without NEC | Biological: premature newborns without NEC<br>* weekly Blood sample and daily Stools sample during 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of volatolomics results of the gut microbiota | Characterization of the gut microbiota using a capture method by hybridization of the gene encoding 16S rRNA | Immediatly after the intervention | 
| comparison of microbiological results of the gut microbiota | Characterization of the gut microbiota using a capture method by hybridization of the gene encoding 16S rRNA | Immediatly after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fungal microbiota | Comparison of the fungal microbiota on 10 NECS and 10 healthy babies | Immediatly after the intervention | 
| Tryptasemia | measurement of blood tryptasemia | Day 1, Day 3, Immediatly after the intervention | 
| environmental xenobiotics | measurement of titane and silicia levels in placental and meconium assays | Day 1 | 
| Milk protein composition | milk protein determination | daily for 12 weekd | 
| Milk lipid composition | milk lipid determination | daily for 12 weekd | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Necrotizing Enterocolitis, prematurity, volatolomic and microbiological signatures, mast cell activation, blood tryptase assay, fungal digestive colonization, fecal calprotectin