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Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction

Conditions
Necrotizing Enterocolitis
Interventions
Other: necrotizing enterocolitis
Registration Number
NCT03869827
Lead Sponsor
Hospices Civils de Lyon
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
378
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.
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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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
IUGRnecrotizing enterocolitisAll 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.
Controlnecrotizing enterocolitisTo 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.
Primary Outcome Measures
NameTimeMethod
Number of patients with Necrotizing Enterocolitis stage 2between 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 1between 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 3between 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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Hôpital Femme Mère Enfant

🇫🇷

Bron, France

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