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Risk Factors of Necrotizing Enterocolitis in Premature Newborns

Identifying Risk Factors of Necrotizing Enterocolitis in the NICU of Nancy Benchmarking With the NICU of Lyon Over 10 Years

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04719546
Acronym
ECUNancyLyon
Enrollment
459
Registered
2021-01-22
Start date
2021-01-21
Completion date
2021-08-31
Last updated
2022-03-04

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

Conditions

Necrotizing Enterocolitis of Newborn, Risk Factors

Brief summary

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.

Interventions

OTHERObservation of related perinatal factors

Data described in Primary outcome measures will be collected in both groups

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Premature newborns (\< 37 weeks of gestation) having done a necrotizing enterocolitis stage II or III according to Bell's criteria.

Exclusion criteria

* Children term born (\> 37 weeks of gestation) * Necrotizing enterocolitis during an hospitalisation outside the NICU of Nancy or Lyon * Malformation or pre-existing digestive pathology * Complex or severe malformative pathologies

Design outcomes

Primary

MeasureTime frameDescription
Necrotizing enterocolitis (NEC)10 yearsNumber of infants with NEC at a Bell stage \> 1 in Nancy as compared to Lyon
Risk factor of NEC during Pregnancy10 yearsNumber of infants who had abnormal pregnancy course in each group (defined as the presence of multiple pregnancy; gestational hypertension; Intrauterine Growth Retardation defined as a birth weight below the 10th Centile of Fenton Curves; Abnormal heart rate at the time of delivery)
Gestational age of infants with NEC10 yearsGestational age in weeks of infants presenting with NEC in Nancy as compared to Lyon

Secondary

MeasureTime frameDescription
NEC occurrence10 yearsAge of NEC onset in Nancy as compared to Lyon
Gender10 yearsRate of baby boys presenting NEC in Nancy as compared to Lyon
Patent Ductus Arteriosus (PDA)10 yearsNumber of enfants presenting a PDA requiring treatment in Nancy as compared to Lyon
Perinatal risk factor of NEC10 yearsNumber of infants who did not receive antenatal maturation by steroids in Nancy as compared to Lyon
Infection10 yearsNumber of infants treated for infection in Nancy as compared to Lyon
Red Blood Cell transfusion10 yearsNumber of infants who required a transfusion before the occurence of NEC in Nancy as compared to Lyon
Feeding10 yearsNumber of infants for each Type of milk at the point of date in Nancy as compared to Lyon (Mothers own milk versus milk bank versus formula )
Place of birth as risk factor for NEC10 yearsNumber of outborn infants in Nancy as compared to Lyon
Asphyxia at birth10 yearsNumber of infants with an APGAR score \< 7 in Nancy as compared to Lyon

Countries

France

Outcome results

None listed

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