Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction (ECUN)

Evaluation of the Risk of Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction.

Necrotizing enterocolitis is the most common gastroenterological emergency in neonatology. Its mortality is high, ranging from 15 to 30%. Prematurity is the main risk factor for necrotizing enterocolitis, as well as the very low birth weight (<1500 g) associated with prematurity. Among the early neonatal complications of intrauterine growth restriction neonates, necrotizing enterocolitis is frequently reported in the literature. The situation of chronic hypoxia of these fetuses is at the origin of a vascular redistribution favoring the cerebral circulation to the detriment of the mesenteric vascularization, which could lead to the development of an necrotizing enterocolitis. However, data from the literature concerning this over-risk of necrotizing enterocolitis in the case of intrauterine growth restriction are discordant. The heterogeneity of the definitions used for the intrauterine growth restriction and diagnostic criteria for necrotizing enterocolitis from one study to another could explain these discrepancies. The investigator's hypothesis is that the risk of necrotizing enterocolitis is higher among newborns in intrauterine growth restriction compared to control children.

Study Overview

• Status: Unknown
• Conditions: Necrotizing Enterocolitis
• Intervention / Treatment: Other: necrotizing enterocolitis

• Study Type: Observational
• Enrollment (Anticipated): 378

Contacts and Locations

Study Locations

• France
  • Bron, France
    • Recruiting
    • Hôpital Femme Mère Enfant
    • Contact: Muriel DORET, Prof.
    • Principal Investigator: Muriel Doret, Prof.

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

All birth between 24 + 0 weeks of amenorrhea and 36 + 6 weeks of amenorrhea with isolated intrauterine growth restriction at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2011 to 31 december 2016.

To each of these children with intrauterine growth restriction is matched a control child: the child without intrauterine growth restriction of the same gestational age whose date of birth is consecutive to that of the case.

Description

Inclusion Criteria:

• All birth between 24 + 0 weeks of amenorrhea and 36 + 6 weeks of amenorrhea
• with isolated intrauterine growth restriction at the maternity ward of the hospital Femme-Mère-Enfant
• from 1st of january 2011 to 31 december 2016.

Inclusion Criteria for control group:

• All birth between 24 + 0 weeks of amenorrhea and 36 + 6 weeks of amenorrhea
• without isolated intrauterine growth restriction at the maternity ward of the hospital Femme-Mère-Enfant
• from 1st of january 2011 to 31 december 2016.

Exclusion Criteria:

• Infants born out of the hospital and secondarily hospitalized in our department
• unaccompanied pregnancies
• multiple pregnancies
• children with malformations or genetic abnormalities,
• medical termination of pregnancy
• fetal deaths in utero

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IUGR; All birth between 24 + 0 weeks of amenorrhea and 36 + 6 weeks of amenorrhea with isolated intrauterine growth restriction at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2011 to 31 december 2016.	Other: necrotizing enterocolitis; Collection of necrotizing enterocolitis diagnosis, as well as its severity, are based on the classification of Belle modified in 3 stages: 1) Suspected, 2) Proven, 3) Advanced
Control; To each of these children with intrauterine growth restriction is matched a control child: the child without intrauterine growth restriction of the same gestational age whose date of birth is consecutive to that of the case.	Other: necrotizing enterocolitis; Collection of necrotizing enterocolitis diagnosis, as well as its severity, are based on the classification of Belle modified in 3 stages: 1) Suspected, 2) Proven, 3) Advanced

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with Necrotizing Enterocolitis stage 1	The necrotizing enterocolitis diagnosis, as well as its severity, are based on the classification of Belle modified in 3 stages: 1) Suspected, 2) Proven, 3) Advanced	between 2011 and 2016
Number of patients with Necrotizing Enterocolitis stage 2	The necrotizing enterocolitis diagnosis, as well as its severity, are based on the classification of Belle modified in 3 stages: 1) Suspected, 2) Proven, 3) Advanced	between 2011 and 2016
Number of patients with Necrotizing Enterocolitis stage 3	The necrotizing enterocolitis diagnosis, as well as its severity, are based on the classification of Belle modified in 3 stages: 1) Suspected, 2) Proven, 3) Advanced	between 2011 and 2016

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Muriel Doret, ¨Prof., Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 14, 2019
• Last Update Submitted That Met QC Criteria: March 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Fetal Diseases; Pregnancy Complications; Growth Disorders; Enterocolitis; Enterocolitis, Necrotizing; Fetal Growth Retardation
• Other Study ID Numbers: ECUN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No