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Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03869827
Acronym
ECUN
Enrollment
378
Registered
2019-03-11
Start date
2018-09-01
Completion date
2019-04-01
Last updated
2019-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotizing Enterocolitis

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.

Interventions

OTHERnecrotizing 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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with Necrotizing Enterocolitis stage 1between 2011 and 2016The 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 2between 2011 and 2016The 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 2016The 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

Countries

France

Contacts

Primary ContactMuriel Doret, Prof.
muriel.doret-dion@chu-lyon.fr4 27 85 51 70

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026