Cohort of Premature Newborns for Charaterization of the Digestive Microbiota in Ulcerative Necrotizing Enterocolitis in Premature Infants (CortECS)

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.

Study Overview

• Status: Completed
• Conditions: Premature Birth; Necrotizing Enterocolitis
• Intervention / Treatment: Biological: premature newborns developing a NEC; Biological: premature newborns without 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

• Study Type: Interventional
• Enrollment (Actual): 297
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 2 minutes (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NEC; premature newborns developing a NEC	Biological: premature newborns developing a NEC; weekly Blood sample and daily Stools sample during 12 weeks + Blood and stool sample during NEC
Active Comparator: Healthy control; premature newborns without NEC	Biological: premature newborns without NEC; weekly Blood sample and daily Stools sample during 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: MEDIS Laboratory; QUAPA; ENTeRisk

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2021
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 7, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: prematurity; Necrotizing Enterocolitis; fecal calprotectin; mast cell activation; volatolomic and microbiological signatures; blood tryptase assay; fungal digestive colonization
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Enterocolitis; Premature Birth; Enterocolitis, Necrotizing
• Other Study ID Numbers: RBHP 2021 PONS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No