Risk Factors of Necrotizing Enterocolitis in Premature Newborns

Study Overview
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Brief Summary
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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.

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

Conditions
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Necrotizing Enterocolitis of Newborn, Risk Factors

Intervention / Treatment
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* Other: Observation of related perinatal factors


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NEC Group<br>All Premature Neonates born in Nancy and Lyon over 10 years and presenting with Necrotizing Enterocolitis | Other: Observation of related perinatal factors<br>* Data described in Primary outcome measures will be collected in both groups<br>|
| Control Group<br>All Premature Neonates born in Nancy and Lyon over 10 years without Necrotizing Enterocolitis throughout the neonatal period | Other: Observation of related perinatal factors<br>* Data described in Primary outcome measures will be collected in both groups<br>|

What is the study measuring?
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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 |