Necrotizing Enterocolitis, Premature Birth
Conditions
Keywords
Necrotizing Enterocolitis, prematurity, volatolomic and microbiological signatures, mast cell activation, blood tryptase assay, fungal digestive colonization, fecal calprotectin
Brief summary
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
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
Interventions
BIOLOGICALpremature newborns developing a NEC
weekly Blood sample and daily Stools sample during 12 weeks + Blood and stool sample during NEC
BIOLOGICALpremature newborns without NEC
weekly Blood sample and daily Stools sample during 12 weeks
Sponsors
University Hospital, Clermont-Ferrand
MEDIS Laboratory
QUAPA
ENTeRisk
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 2 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| comparison of volatolomics results of the gut microbiota | Immediatly after the intervention | Characterization of the gut microbiota using a capture method by hybridization of the gene encoding 16S rRNA |
| comparison of microbiological results of the gut microbiota | Immediatly after the intervention | Characterization of the gut microbiota using a capture method by hybridization of the gene encoding 16S rRNA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fungal microbiota | Immediatly after the intervention | Comparison of the fungal microbiota on 10 NECS and 10 healthy babies |
| Tryptasemia | Day 1, Day 3, Immediatly after the intervention | measurement of blood tryptasemia |
| environmental xenobiotics | Day 1 | measurement of titane and silicia levels in placental and meconium assays |
| Milk protein composition | daily for 12 weekd | milk protein determination |
| Milk lipid composition | daily for 12 weekd | milk lipid determination |
Countries
France
Outcome results
None listed