Risk Factors of Necrotizing Enterocolitis in Premature Newborns

Risk Factors Clinical Trial

— ECUNancyLyon  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04719546
• Other study ID #: 2020PI279
• Status: Completed
• Start date: January 21, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: March 2022
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 459
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis of Newborn
• Risk Factors

Intervention

Other:
• Observation of related perinatal factors
Data described in Primary outcome measures will be collected in both groups

Locations

Country	Name	City	State
France	CHU LYON	Bron
France	Maternite Regionale Universitaire CHRU NANCY	Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Necrotizing enterocolitis (NEC)	Number of infants with NEC at a Bell stage > 1 in Nancy as compared to Lyon	10 years
Primary	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
Primary	Gestational age of infants with NEC	Gestational age in weeks of infants presenting with NEC in Nancy as compared to Lyon	10 years
Secondary	Perinatal risk factor of NEC	Number of infants who did not receive antenatal maturation by steroids in Nancy as compared to Lyon	10 years
Secondary	Place of birth as risk factor for NEC	Number of outborn infants in Nancy as compared to Lyon	10 years
Secondary	Asphyxia at birth	Number of infants with an APGAR score < 7 in Nancy as compared to Lyon	10 years
Secondary	NEC occurrence	Age of NEC onset in Nancy as compared to Lyon	10 years
Secondary	Gender	Rate of baby boys presenting NEC in Nancy as compared to Lyon	10 years
Secondary	Patent Ductus Arteriosus (PDA)	Number of enfants presenting a PDA requiring treatment in Nancy as compared to Lyon	10 years
Secondary	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
Secondary	Infection	Number of infants treated for infection in Nancy as compared to Lyon	10 years
Secondary	Red Blood Cell transfusion	Number of infants who required a transfusion before the occurence of NEC in Nancy as compared to Lyon	10 years