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

Premature Birth Clinical Trial

— CortECS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04972734
• Other study ID #: RBHP 2021 PONS
• Status: Recruiting
• Phase: N/A
• Start date: July 2, 2021
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2024
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 04 73 75 11 95
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 2 Minutes

Eligibility

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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis
• Premature Birth

Intervention

Biological:
• 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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	ENTeRisk, MEDIS Laboratory, QUAPA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Fungal microbiota	Comparison of the fungal microbiota on 10 NECS and 10 healthy babies	Immediatly after the intervention
Secondary	Tryptasemia	measurement of blood tryptasemia	Day 1, Day 3, Immediatly after the intervention
Secondary	environmental xenobiotics	measurement of titane and silicia levels in placental and meconium assays	Day 1
Secondary	Milk protein composition	milk protein determination	daily for 12 weekd
Secondary	Milk lipid composition	milk lipid determination	daily for 12 weekd