Clinical trial NCT04972734: Cohort of Premature Newborns for Charaterization of the Digestive Microbiota in Ulcerative Necrotizing Enterocolitis in Premature Infants
Official title: Cohort of Premature Newborns for Charaterization of the Digestive Microbiota in Ulcerative Necrotizing Enterocolitis in Premature Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Necrotizing Enterocolitis
Premature Birth
Keywords: Necrotizing Enterocolitis
prematurity
volatolomic and microbiological signatures
mast cell activation
blood tryptase assay
fungal digestive colonization
fecal calprotectin
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: MEDIS Laboratory
name: QUAPA
name: ENTeRisk
First posted: 2021-07-22
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: comparison of volatolomics results of the gut microbiota
timeFrame: Immediatly after the intervention
measure: comparison of microbiological results of the gut microbiota
timeFrame: Immediatly after the intervention
Secondary outcomes:
measure: Fungal microbiota
timeFrame: Immediatly after the intervention
measure: Tryptasemia
timeFrame: Day 1, Day 3, Immediatly after the intervention
measure: environmental xenobiotics
timeFrame: Day 1
measure: Milk protein composition
timeFrame: daily for 12 weekd
measure: Milk lipid composition
timeFrame: daily for 12 weekd
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
References: