Risk Factors of Necrotizing Enterocolitis in Premature Newborns (ECUNancyLyon)

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

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.

Study Overview

• Status: Completed
• Conditions: Risk Factors; Necrotizing Enterocolitis of Newborn
• Intervention / Treatment: Other: Observation of related perinatal factors

• Study Type: Observational
• Enrollment (Actual): 459

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • CHU Lyon
  • Lorraine
    • Nancy, Lorraine, France, 54035
      • Maternite Regionale Universitaire CHRU NANCY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• Premature newborns (< 37 weeks of gestation) having done a necrotizing enterocolitis stage II or III according to Bell's criteria.
• Premature newborns (< 37 weeks of gestation) having grown up without nectrotizing enterocolitis at the same period of time, in order to associate 2 witness patient to one case patient.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NEC Group; All Premature Neonates born in Nancy and Lyon over 10 years and presenting with Necrotizing Enterocolitis	Other: 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	Other: Observation of related perinatal factors; Data described in Primary outcome measures will be collected in both groups

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2021
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Enterocolitis; Enterocolitis, Necrotizing
• Other Study ID Numbers: 2020PI279

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No