Risk Factors of Necrotizing Enterocolitis in Premature Newborns

Completed

• Conditions: Necrotizing Enterocolitis of Newborn; Risk Factors
• Interventions: Other: Observation of related perinatal factors

• Registration Number: NCT04719546
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-14
• Study Start: 2021-01-21
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-22
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 459

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group	Observation of related perinatal factors	All Premature Neonates born in Nancy and Lyon over 10 years without Necrotizing Enterocolitis throughout the neonatal period
NEC Group	Observation of related perinatal factors	All Premature Neonates born in Nancy and Lyon over 10 years and presenting with Necrotizing Enterocolitis

Primary Outcome Measures

Name	Time	Method
Necrotizing enterocolitis (NEC)	10 years	Number of infants with NEC at a Bell stage \> 1 in Nancy as compared to Lyon
Risk factor of NEC during Pregnancy	10 years	Number 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 NEC	10 years	Gestational age in weeks of infants presenting with NEC in Nancy as compared to Lyon

Secondary Outcome Measures

Name	Time	Method
NEC occurrence	10 years	Age of NEC onset in Nancy as compared to Lyon
Red Blood Cell transfusion	10 years	Number of infants who required a transfusion before the occurence of NEC in Nancy as compared to Lyon
Perinatal risk factor of NEC	10 years	Number of infants who did not receive antenatal maturation by steroids in Nancy as compared to Lyon
Gender	10 years	Rate of baby boys presenting NEC in Nancy as compared to Lyon
Place of birth as risk factor for NEC	10 years	Number of outborn infants in Nancy as compared to Lyon
Asphyxia at birth	10 years	Number of infants with an APGAR score \< 7 in Nancy as compared to Lyon
Patent Ductus Arteriosus (PDA)	10 years	Number of enfants presenting a PDA requiring treatment in Nancy as compared to Lyon
Feeding	10 years	Number 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 )
Infection	10 years	Number of infants treated for infection in Nancy as compared to Lyon

Trial Locations

Locations (2)

CHU LYON; 🇫🇷 Bron, France

Maternite Regionale Universitaire CHRU NANCY; 🇫🇷 Nancy, Lorraine, France