Clinical trial NCT04584320: 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
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Necrotizing Enterocolitis
Keywords: low-birth weight infant
Clostridium butyricum
Clostridium neonatale
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Presence of C. butyricum
timeFrame: Each day of hospitalization (maximum 120 days)
measure: Presence of C. neonatale
timeFrame: Each day of hospitalization (maximum 120 days)
measure: Culture of C. butyricum
timeFrame: Each day of hospitalization (maximum 120 days)
measure: Culture of C. neonatale
timeFrame: Each day of hospitalization (maximum 120 days)
Secondary outcomes:
measure: Localisation within the hospital
timeFrame: During hospitalization (maximum 120 days)
Other outcomes:
measure: Age of mother
timeFrame: Day 0
measure: Body mass index of mother
timeFrame: Day 0
measure: Parity of mother
timeFrame: Day 0
measure: Gravidity of mother
timeFrame: Day 0
measure: Professional activity of mother
timeFrame: Day 0
measure: Smoking status of mother
timeFrame: Day 0
measure: Chronic pathology of mother
timeFrame: Day 0
measure: Allergy of mother
timeFrame: Day 0
measure: Number of years of schooling of mother
timeFrame: Day 0
measure: Exposure to magnesium sulfate during pregnancy
timeFrame: Day 0
measure: Cause of prematurity
timeFrame: Day 0
measure: Method of delivery
timeFrame: Day 0
measure: Anesthesia during delivery
timeFrame: Day 0
measure: Mode of delivery of vaginal birth
timeFrame: Day 0
measure: Spontaneous rupture of membranes
timeFrame: Day 0
measure: Time of rupture of membranes before birth
timeFrame: Day 0
measure: Pathology during pregnancy
timeFrame: Day 0
measure: Birth term
timeFrame: Day 0
measure: Birth weight
timeFrame: Day 0
measure: Birth weight percentile
timeFrame: Day 0
measure: Birth height
timeFrame: Day 0
measure: Birth height ; percentile
timeFrame: Day 0
measure: Intubation
timeFrame: Day 0
measure: umbilical venous catheter
timeFrame: Day 0
measure: Epicutaneo-cava catheter
timeFrame: Day 0
measure: Daily lipid intake per os per kilp
timeFrame: During hospitlization (maximum 120 days)
measure: Presence of sequelae
timeFrame: During hospitalization (maximum 120 days)
measure: Type of sequelae
timeFrame: During hospitalization (maximum 120 days)
measure: Hemodynamically significant patent ductus arteriosus
timeFrame: During hospitalization (maximum 120 days)
measure: Type of milk
timeFrame: During hospitalization (maximum 120 days)
measure: Duration of milk intake
timeFrame: During hospitalization (maximum 120 days)
measure: Probiotic intake duration
timeFrame: During hospitalization (maximum 120 days)
measure: Types of probiotic taken
timeFrame: During hospitalization (maximum 120 days)
measure: Type of antibiotics taken in post-natal period
timeFrame: During hospitalization (maximum 120 days)
measure: Duration of antibiotic treatment in post-natal period
timeFrame: During hospitalization (maximum 120 days)
measure: Type of vasoactive amines taken
timeFrame: During hospitalization (maximum 120 days)
measure: Duration of vasoactive amine treatment
timeFrame: During hospitalization (maximum 120 days)
measure: Type of any postnatal surgery
timeFrame: During hospitalization (maximum 120 days)
measure: Total duration of parenteral feeding
timeFrame: During hospitalization (maximum 120 days)
measure: Ibuprofen
timeFrame: During hospitalization (maximum 120 days)
measure: Hemodynamic shock
timeFrame: During hospitalization (maximum 120 days)
measure: Labile Blood Product transfusion
timeFrame: During hospitalization (maximum 120 days)
measure: antenatal corticosteroid therapy
timeFrame: Day 0
measure: Type of post-natal corticosteroid therapy
timeFrame: During hospitalization (maximum 120 days)
measure: Duration of post-natal corticosteroid therapy
timeFrame: During hospitalization (maximum 120 days)
measure: Exposure to ante- and post-natal antibiotics
timeFrame: During hospitalization (maximum 120 days)
measure: umbilical arterial catheter
timeFrame: Day 0
measure: Nosocomial infection
timeFrame: During hospitalization (maximum 120 days)
measure: Nosocomial infection infective agent
timeFrame: During hospitalization (maximum 120 days)
measure: Rectal bleeding
timeFrame: During hospitalization (maximum 120 days)
measure: metabolic acidosis
timeFrame: During hospitalization (maximum 120 days)
measure: Volume of alimentation per kilo
timeFrame: During hospitalization (maximum 120 days)
measure: Daily carbohydrate intake per os per kilp
timeFrame: During hospitalization (maximum 120 days)
measure: Daily proteins intake per os per kilp
timeFrame: During hospitalization (maximum 120 days)
measure: Volume of daily total alimentation
timeFrame: During hospitalization (maximum 120 days)
measure: Cranial circumference
timeFrame: Day 0
measure: Cranial circumference percentile
timeFrame: Day 0
measure: Other catheter
timeFrame: Day 0
measure: Duration of other catheter
timeFrame: Day 0
measure: Enriched maternal milk
timeFrame: During hospitalization (maximum 120 days)
measure: Milk thickening
timeFrame: During hospitalization (maximum 120 days)
measure: Chorioamnionitis
timeFrame: During hospitalization (maximum 120 days)
measure: Materno-fetal infection
timeFrame: Day 0
measure: Materno-fetal infection infective agent
timeFrame: Day 0
measure: pneumatosis-pneumoportia
timeFrame: During hospitalization (maximum 120 days)
measure: Transfer
timeFrame: During hospitalization (maximum 120 days)
measure: Time of occurence of ulcerative necrotizing enterocolitis
timeFrame: During hospitalization (maximum 120 days)
measure: Warning signs of ulcerative necrotizing enterocolitis
timeFrame: During hospitalization (maximum 120 days)
measure: Duration of bowel rest following necrotizing enterocolitis
timeFrame: During hospitalization (maximum 120 days)
measure: Bell staging of ulcerative necrotizing enterocolitis
timeFrame: During hospitalization (maximum 120 days)
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU Nimes
name: Massimo De Maio
role: PRINCIPAL_INVESTIGATOR
References: