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

NCT04972734 | Unknown

• 1 other identifier: RBHP 2021 PONS
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Necrotizing Enterocolitis; Premature Birth

Keywords

Necrotizing Enterocolitis; prematurity; volatolomic and microbiological signatures; mast cell activation; blood tryptase assay; fungal digestive colonization; fecal calprotectin

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Fungal microbiota

  Immediatly after the intervention

• Tryptasemia

  Day 1, Day 3, Immediatly after the intervention

• environmental xenobiotics

  Day 1

• Milk protein composition

  daily for 12 weekd

• Milk lipid composition

  daily for 12 weekd

Study Arms (2)

NEC

EXPERIMENTAL

premature newborns developing a NEC

Biological: premature newborns developing a NEC

Healthy control

ACTIVE COMPARATOR

premature newborns without NEC

Biological: premature newborns without NEC

Interventions

premature newborns developing a NEC BIOLOGICAL

weekly Blood sample and daily Stools sample during 12 weeks + Blood and stool sample during NEC

NEC

premature newborns without NEC BIOLOGICAL

weekly Blood sample and daily Stools sample during 12 weeks

Healthy control

Eligibility Criteria

• Age: 1 Minute - 2 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• MEDIS Laboratory: collaborator
• QUAPA: collaborator
• ENTeRisk: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Premature Birth

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Lise Laclautre

CONTACT

04 73 75 11 95; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 22, 2021
• Study Start: July 2, 2021
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)