Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction

Necrotizing Enterocolitis Clinical Trial

— ECUN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03869827
• Other study ID #: ECUN
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: March 2019
• Source: Hospices Civils de Lyon
• Contact: Muriel Doret, Prof.
• Phone: 4 27 85 51 70
• Email: muriel.doret-dion[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 378
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Fetal Growth Retardation
• Necrotizing Enterocolitis

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Femme Mère Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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