Identification of Clostridium Butyricum and Clostridium Neonatal in the Digestive Microbiota of Premature Infants Before 34 Weeks and Developing or Not Ulcerative Necrotizing Enterocolitis (NEC) During Hospitalization

NCT04584320 | Active Not Recruiting

• 1 other identifier: NIMAO/2019-01/MdM01
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study investigators hypothesize that Clostridium butyricum and Clostridium neonatal will be more frequently found in the stool of preterm infants with ulcerative necrotizing enterocolitis compared to healthy matched control infants. Systematic daily samples should show that the kinetics of colonization precedes the onset of the pathology. Finally, the systematic ecological survey at the time of infection could help understand the mode of acquisition and transmission of these bacteria.

Conditions

Necrotizing Enterocolitis

Keywords

low-birth weight infant; Clostridium butyricum; Clostridium neonatale

Outcome Measures

Primary Outcomes (4)

• Presence of C. butyricum

  PCR

  Each day of hospitalization (maximum 120 days)

• Presence of C. neonatale

  PCR

  Each day of hospitalization (maximum 120 days)

• Culture of C. butyricum

  Growth on selective media

  Each day of hospitalization (maximum 120 days)

• Culture of C. neonatale

  Growth on selective media

  Each day of hospitalization (maximum 120 days)

Secondary Outcomes (1)

• Localisation within the hospital

  During hospitalization (maximum 120 days)

Other Outcomes (70)

• Age of mother

  Day 0

• Body mass index of mother

  Day 0

• Parity of mother

  Day 0

Study Arms (2)

Premature neonates with necrotizing enterocolitis

Other: Stool sample

Premature neonates without necrotizing enterocolitis

Other: Stool sample

Interventions

Stool sample OTHER

Stools samples taken daily to test for present of Clostridium butyricum and Clostridium neonatale

Premature neonates with necrotizing enterocolitis; Premature neonates without necrotizing enterocolitis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of all newborns born less than 34 weeks of gestation admitted to the neonatology department of the CHU de Nîmes.

You may qualify if:

• Premature newborn with a term of birth ≤ 34 weeks of gestation admitted to the neonatology department at the CHU of Nîmes.
• Affiliated or beneficiary of a health insurance plan.
• Newborn whose parents received informed information about the study and did not express their opposition to their child's participation in the study.

You may not qualify if:

• Newborn with malformative digestive pathology
• Newborn baby participating in another category 1 trial

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nimes

Nîmes, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool samples taken daily from nappies

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Massimo De Maio

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 12, 2020
• Study Start: October 18, 2021
• Primary Completion: November 9, 2024
• Study Completion: October 1, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

FR (1)