Trials / Unknown
UnknownNCT03869827
Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction
Evaluation of the Risk of Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction.
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 378 (estimated)
- Sponsor
- Hospices Civils de Lyon · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-09-01
- Primary completion
- 2019-04-01
- Completion
- 2019-04-01
- First posted
- 2019-03-11
- Last updated
- 2019-03-14
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03869827. Inclusion in this directory is not an endorsement.