Clinical trial NCT04719546: Risk Factors of Necrotizing Enterocolitis in Premature Newborns
Official title: Identifying Risk Factors of Necrotizing Enterocolitis in the NICU of Nancy Benchmarking With the NICU of Lyon Over 10 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Necrotizing Enterocolitis of Newborn
Risk Factors
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 459
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Necrotizing enterocolitis (NEC)
timeFrame: 10 years
measure: Risk factor of NEC during Pregnancy
timeFrame: 10 years
measure: Gestational age of infants with NEC
timeFrame: 10 years
Secondary outcomes:
measure: Perinatal risk factor of NEC
timeFrame: 10 years
measure: Place of birth as risk factor for NEC
timeFrame: 10 years
measure: Asphyxia at birth
timeFrame: 10 years
measure: NEC occurrence
timeFrame: 10 years
measure: Gender
timeFrame: 10 years
measure: Patent Ductus Arteriosus (PDA)
timeFrame: 10 years
measure: Feeding
timeFrame: 10 years
measure: Infection
timeFrame: 10 years
measure: Red Blood Cell transfusion
timeFrame: 10 years
Other outcomes:
Locations:
city: Nancy
country: France
facility: Maternite Regionale Universitaire CHRU NANCY
state: Lorraine
city: Bron
country: France
facility: CHU LYON
Study officials:
References: