An observational study in Necrotizing Enterocolitis, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Per ClinicalTrials.gov, last updated 2019-03-14.
Sponsored by Hospices Civils de Lyon · Observational
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.
216 studies on the registry are indexed under Enterocolitis; 26 are open to participants now.
This study's planned enrollment of 378 is above the median of 78 across 86 observational studies indexed under Enterocolitis.
Browse Enterocolitis studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
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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.
To 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.
Inclusion Criteria:
Inclusion Criteria for control group:
Exclusion 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.
Other: necrotizing enterocolitis
To 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.
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
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
Time frame: between 2011 and 2016
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
Time frame: between 2011 and 2016
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
Time frame: between 2011 and 2016
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon