Back to resultsCohort of Premature Newborns for Charaterization of the Digestive Microbiota in Ulcerative Necrotizing Enterocolitis in Premature Infants (CortECS)
Primary Purpose
Necrotizing Enterocolitis, Premature Birth
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
premature newborns developing a NEC
premature newborns without NEC
Sponsored by
About this trial
This is an interventional other trial for Necrotizing Enterocolitis focused on measuring Necrotizing Enterocolitis, prematurity, volatolomic and microbiological signatures, mast cell activation, blood tryptase assay, fungal digestive colonization, fecal calprotectin
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
Sites / Locations
- CHU Clermont-FerrandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NEC
Healthy control
Arm Description
premature newborns developing a NEC
premature newborns without NEC
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Fungal microbiota
Comparison of the fungal microbiota on 10 NECS and 10 healthy babies
Tryptasemia
measurement of blood tryptasemia
environmental xenobiotics
measurement of titane and silicia levels in placental and meconium assays
Milk protein composition
milk protein determination
Milk lipid composition
milk lipid determination
Full Information
NCT ID
NCT04972734
First Posted
June 28, 2021
Last Updated
August 16, 2021
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
MEDIS Laboratory, QUAPA, ENTeRisk
1. Study Identification
Unique Protocol Identification Number
NCT04972734
Brief Title
Cohort of Premature Newborns for Charaterization of the Digestive Microbiota in Ulcerative Necrotizing Enterocolitis in Premature Infants
Acronym
CortECS
Official Title
Cohort of Premature Newborns for Charaterization of the Digestive Microbiota in Ulcerative Necrotizing Enterocolitis in Premature Infants
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 2, 2021 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
MEDIS Laboratory, QUAPA, ENTeRisk
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotizing Enterocolitis, Premature Birth
Keywords
Necrotizing Enterocolitis, prematurity, volatolomic and microbiological signatures, mast cell activation, blood tryptase assay, fungal digestive colonization, fecal calprotectin
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NEC
Arm Type
Experimental
Arm Description
premature newborns developing a NEC
Arm Title
Healthy control
Arm Type
Active Comparator
Arm Description
premature newborns without NEC
Intervention Type
Biological
Intervention Name(s)
premature newborns developing a NEC
Intervention Description
weekly Blood sample and daily Stools sample during 12 weeks + Blood and stool sample during NEC
Intervention Type
Biological
Intervention Name(s)
premature newborns without NEC
Intervention Description
weekly Blood sample and daily Stools sample during 12 weeks
Primary Outcome Measure Information:
Title
comparison of volatolomics results of the gut microbiota
Description
Characterization of the gut microbiota using a capture method by hybridization of the gene encoding 16S rRNA
Time Frame
Immediatly after the intervention
Title
comparison of microbiological results of the gut microbiota
Description
Characterization of the gut microbiota using a capture method by hybridization of the gene encoding 16S rRNA
Time Frame
Immediatly after the intervention
Secondary Outcome Measure Information:
Title
Fungal microbiota
Description
Comparison of the fungal microbiota on 10 NECS and 10 healthy babies
Time Frame
Immediatly after the intervention
Title
Tryptasemia
Description
measurement of blood tryptasemia
Time Frame
Day 1, Day 3, Immediatly after the intervention
Title
environmental xenobiotics
Description
measurement of titane and silicia levels in placental and meconium assays
Time Frame
Day 1
Title
Milk protein composition
Description
milk protein determination
Time Frame
daily for 12 weekd
Title
Milk lipid composition
Description
milk lipid determination
Time Frame
daily for 12 weekd
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
2 Minutes
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
04 73 75 11 95
Email
promo_interne_drci@chu-clermontferrand.fr
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Phone
04 73 75 11 95
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Maguelonne PONS
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cohort of Premature Newborns for Charaterization of the Digestive Microbiota in Ulcerative Necrotizing Enterocolitis in Premature Infants
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