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Clinical Trials/NCT03869827
NCT03869827
Unknown
Not Applicable

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

Hospices Civils de Lyon1 site in 1 country378 target enrollmentSeptember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Necrotizing Enterocolitis
Sponsor
Hospices Civils de Lyon
Enrollment
378
Locations
1
Primary Endpoint
Number of patients with Necrotizing Enterocolitis stage 2
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
April 1, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • 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

Outcomes

Primary Outcomes

Number of patients with Necrotizing Enterocolitis stage 2

Time Frame: between 2011 and 2016

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

Number of patients with Necrotizing Enterocolitis stage 1

Time Frame: between 2011 and 2016

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

Number of patients with Necrotizing Enterocolitis stage 3

Time Frame: between 2011 and 2016

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

Study Sites (1)

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