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 (ECUN-2)

Qualitative and Quantitative 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 Their Hospitalization in Neonatology

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Necrotizing Enterocolitis
• Intervention / Treatment: Other: Stool sample

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• France
  • Nîmes, France
    • CHU de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Premature neonates with necrotizing enterocolitis	Other: Stool sample; Stools samples taken daily to test for present of Clostridium butyricum and Clostridium neonatale
Premature neonates without necrotizing enterocolitis	Other: Stool sample; Stools samples taken daily to test for present of Clostridium butyricum and Clostridium neonatale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Localisation within the hospital	Bed numbers occupied	During hospitalization (maximum 120 days)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age of mother	Years	Day 0
Body mass index of mother	Kg/m2	Day 0
Parity of mother		Day 0
Gravidity of mother		Day 0
Professional activity of mother	Yes/no; description	Day 0
Smoking status of mother	Yes/no	Day 0
Chronic pathology of mother	Yes/no, description	Day 0
Allergy of mother	Yes/no, description	Day 0
Number of years of schooling of mother		Day 0
Exposure to magnesium sulfate during pregnancy	Yes/no	Day 0
Cause of prematurity		Day 0
Method of delivery	Vagina/Caesarean	Day 0
Anesthesia during delivery	General/spinal	Day 0
Mode of delivery of vaginal birth	Spontaneous/instrumental	Day 0
Spontaneous rupture of membranes	Yes/no	Day 0
Time of rupture of membranes before birth	<12h/>12h	Day 0
Pathology during pregnancy	Yes/No; description	Day 0
Birth term	Weeks and days	Day 0
Birth weight	grams	Day 0
Birth weight percentile	percentile	Day 0
Birth height	cm	Day 0
Birth height ; percentile	percentile	Day 0
Intubation	Yes/no	Day 0
umbilical venous catheter	Yes/no; duration	Day 0
Epicutaneo-cava catheter	Yes/no; duration	Day 0
Daily lipid intake per os per kilp	g/kg	During hospitlization (maximum 120 days)
Presence of sequelae	Yes/no	During hospitalization (maximum 120 days)
Type of sequelae	description	During hospitalization (maximum 120 days)
Hemodynamically significant patent ductus arteriosus	Yes/no	During hospitalization (maximum 120 days)
Type of milk	pasteurized/fresh/artificial	During hospitalization (maximum 120 days)
Duration of milk intake	Days	During hospitalization (maximum 120 days)
Probiotic intake duration	Days	During hospitalization (maximum 120 days)
Types of probiotic taken	Type	During hospitalization (maximum 120 days)
Type of antibiotics taken in post-natal period	Type	During hospitalization (maximum 120 days)
Duration of antibiotic treatment in post-natal period	Days	During hospitalization (maximum 120 days)
Type of vasoactive amines taken	Type	During hospitalization (maximum 120 days)
Duration of vasoactive amine treatment	Days	During hospitalization (maximum 120 days)
Type of any postnatal surgery	Type	During hospitalization (maximum 120 days)
Total duration of parenteral feeding	Days	During hospitalization (maximum 120 days)
Ibuprofen	Yes/no	During hospitalization (maximum 120 days)
Hemodynamic shock	Yes/no	During hospitalization (maximum 120 days)
Labile Blood Product transfusion	Amount	During hospitalization (maximum 120 days)
antenatal corticosteroid therapy	Complete/incomplete	Day 0
Type of post-natal corticosteroid therapy	Type	During hospitalization (maximum 120 days)
Duration of post-natal corticosteroid therapy	Days	During hospitalization (maximum 120 days)
Exposure to ante- and post-natal antibiotics	Description	During hospitalization (maximum 120 days)
umbilical arterial catheter	Duration	Day 0
Nosocomial infection	Proven/suspected	During hospitalization (maximum 120 days)
Nosocomial infection infective agent	name	During hospitalization (maximum 120 days)
Rectal bleeding	Number	During hospitalization (maximum 120 days)
metabolic acidosis	Yes/no	During hospitalization (maximum 120 days)
Volume of alimentation per kilo		During hospitalization (maximum 120 days)
Daily carbohydrate intake per os per kilp	g/kg	During hospitalization (maximum 120 days)
Daily proteins intake per os per kilp	g/kg	During hospitalization (maximum 120 days)
Volume of daily total alimentation		During hospitalization (maximum 120 days)
Cranial circumference	cm; percentile	Day 0
Cranial circumference percentile	percentile	Day 0
Other catheter	Type	Day 0
Duration of other catheter	Days	Day 0
Enriched maternal milk	Maximum percentage	During hospitalization (maximum 120 days)
Milk thickening	Duration	During hospitalization (maximum 120 days)
Chorioamnionitis	Proven/suspected	During hospitalization (maximum 120 days)
Materno-fetal infection	Proven/suspected	Day 0
Materno-fetal infection infective agent	name	Day 0
pneumatosis-pneumoportia	Yes/no	During hospitalization (maximum 120 days)
Transfer	Yes/no	During hospitalization (maximum 120 days)
Time of occurence of ulcerative necrotizing enterocolitis	weeks post-natal	During hospitalization (maximum 120 days)
Warning signs of ulcerative necrotizing enterocolitis		During hospitalization (maximum 120 days)
Duration of bowel rest following necrotizing enterocolitis		During hospitalization (maximum 120 days)
Bell staging of ulcerative necrotizing enterocolitis	from IA (suspected necrotizing enterocolitis) to IIIB (advanced necrotizing enterocolitis)	During hospitalization (maximum 120 days)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Massimo De Maio, CHU Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Actual): November 9, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: October 1, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 12, 2020

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: low-birth weight infant; Clostridium butyricum; Clostridium neonatale
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Enterocolitis; Enterocolitis, Necrotizing
• Other Study ID Numbers: NIMAO/2019-01/MdM01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No