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| Name | Class |
|---|---|
| MEDIS Laboratory | UNKNOWN |
| QUAPA | UNKNOWN |
| ENTeRisk | UNKNOWN |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEC | Experimental | premature newborns developing a NEC |
|
| Healthy control | Active Comparator | premature newborns without NEC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| premature newborns developing a NEC | Biological | weekly Blood sample and daily Stools sample during 12 weeks + Blood and stool sample during NEC |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | France |
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| premature newborns without NEC | Biological | weekly Blood sample and daily Stools sample during 12 weeks |
|
| 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 |
| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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