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

Necrotizing Enterocolitis Clinical Trial

— ECUN-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04584320
• Other study ID #: NIMAO/2019-01/MdM01
• Status: Recruiting
• Start date: October 18, 2021
• Est. completion date: October 2025

Study information

• Verified date: June 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Massimo De Maio
• Phone: 04.66.68.33.05
• Email: massimo.dimaio[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Intervention

Other:
• Stool sample
Stools samples taken daily to test for present of Clostridium butyricum and Clostridium neonatale

Locations

Country	Name	City	State
France	CHU de Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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