Cohort of Premature Newborns for Charaterization of the Digestive Microbiota in Ulcerative Necrotizing Enterocolitis in Premature Infants
NCT ID: NCT04972734
Last Updated: 2024-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2021-07-02
2025-01-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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NEC
premature newborns developing a NEC
premature newborns developing a NEC
weekly Blood sample and daily Stools sample during 12 weeks + Blood and stool sample during NEC
Healthy control
premature newborns without NEC
premature newborns without NEC
weekly Blood sample and daily Stools sample during 12 weeks
Interventions
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premature newborns developing a NEC
weekly Blood sample and daily Stools sample during 12 weeks + Blood and stool sample during NEC
premature newborns without NEC
weekly Blood sample and daily Stools sample during 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* newborns whose holders of parental authority are under guardianship or under the age of 18
* refusal of participation by holders of parental authority
1 Minute
2 Minutes
ALL
No
Sponsors
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MEDIS Laboratory
UNKNOWN
QUAPA
UNKNOWN
ENTeRisk
UNKNOWN
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Locations
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CHU Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RBHP 2021 PONS
Identifier Type: -
Identifier Source: org_study_id
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