Risk Factors of Necrotizing Enterocolitis in Premature Newborns
NCT ID: NCT04719546
Last Updated: 2022-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
459 participants
OBSERVATIONAL
2021-01-21
2021-08-31
Brief Summary
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NEC is an acquired disease, caused by inflammation of the intestinal lining. It is the most common life-threatening gastrointestinal emergency of prematurity, associated with a significant morbidity and mortality.
The etiology and physiopathology are multifactorial, complex, and remain poorly understood. The mechanism of the lesions seems to involve factors including immaturity of the intestinal barrier and the immune system, microvascular imbalance, disturbed gut flora and systemic inflammation.
Despite improved knowledge about this disease, the proportion of surviving patients has not improved for several years. It frequently leads to long-term sequelae depending on the severity of the NEC and its treatment.
Early diagnosis and early treatment of NEC may reduce the risk of mortality and morbidity. The aim of this retrospective bi-centric study is to look for risk factors allowing the prediction of NEC in order to prevent and improve the early management of this disease.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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NEC Group
All Premature Neonates born in Nancy and Lyon over 10 years and presenting with Necrotizing Enterocolitis
Observation of related perinatal factors
Data described in Primary outcome measures will be collected in both groups
Control Group
All Premature Neonates born in Nancy and Lyon over 10 years without Necrotizing Enterocolitis throughout the neonatal period
Observation of related perinatal factors
Data described in Primary outcome measures will be collected in both groups
Interventions
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Observation of related perinatal factors
Data described in Primary outcome measures will be collected in both groups
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Necrotizing enterocolitis during an hospitalisation outside the NICU of Nancy or Lyon
* Malformation or pre-existing digestive pathology
* Complex or severe malformative pathologies
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Jean-Michel HASCOET
Professor
Locations
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Maternite Regionale Universitaire CHRU NANCY
Nancy, Lorraine, France
CHU LYON
Bron, , France
Countries
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Other Identifiers
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2020PI279
Identifier Type: -
Identifier Source: org_study_id
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