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NCT04719546: ECUNancyLyon
Risk Factors of Necrotizing Enterocolitis in Premature Newborns
trial testing Observation of related perinatal factors in Necrotizing Enterocolitis of Newborn in 459 participants. Completed in 31 August 2021.
31 August 2021
Quick facts
| Lead sponsor | Central Hospital, Nancy, France |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 459 |
| Start date | 21 January 2021 |
| Primary completion | 31 August 2021 |
| Estimated completion | 31 August 2021 |
| Sites | 2 locations across France |
Drugs / interventions tested
- Observation of related perinatal factors
Conditions studied
- Necrotizing Enterocolitis of Newborn — all drugs for Necrotizing Enterocolitis of Newborn →
- Risk Factors — all drugs for Risk Factors →
Sponsor
Central Hospital, Nancy, France
Who can join
Eligibility, any sex, with Necrotizing Enterocolitis of Newborn or Risk Factors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
With premature newborn increase survival, the risk of serious neonatal morbidity, such as necrotizing enterocolitis (NEC), also increased. NEC affects between 2 to 7% of premature infants including 5 to 22% of newborns weighing less than 1000 g. 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04719546
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other recruiting trials for Necrotizing Enterocolitis of Newborn
Currently open trials in the same condition.
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- NCT06632314 — Impact of Enteral Feeding on Splanchnic Oxygenation During Packed Red Blood Cell Transfusion in Preterm Infants · NA · active not recruiting
- NCT03997266 — NICU Antibiotics and Outcomes Trial · Phase 4 · active not recruiting
Other Central Hospital, Nancy, France trials
Trials by the same sponsor.
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- NCT07414667 — Primary Sjögren's Syndrome: Impact of Quantitative Anti-Ro52 Antibody Analysis on Patient Prognosis and Stratification ( · not yet recruiting
- NCT07415759 — Imaging of Electrical Properties by MRI: Investigation of Age-Related Changes · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04719546 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Central Hospital, Nancy, France
- Last refreshed: 4 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04719546.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing