Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction

NCT03869827 | Unknown

• 1 other identifier: ECUN
• Study Type: observational
• Target: 378
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Necrotizing Enterocolitis

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

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

Interventions

necrotizing enterocolitis OTHER

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; IUGR

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

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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Femme Mère Enfant

Bron, France

RECRUITING

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

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

Study Officials

• Muriel Doret, ¨Prof.

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muriel Doret, Prof.

CONTACT

4 27 85 51 70; muriel.doret-dion@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 11, 2019
• Study Start: September 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: March 14, 2019

Record last verified: 2019-03

Locations

FR (1)