Identifying Risk Factors of Necrotizing Enterocolitis in the NICU of Nancy Benchmarking With the NICU of Lyon Over 10 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 459
- 试验地点
- 2
- 主要终点
- Necrotizing enterocolitis (NEC)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature newborns (< 37 weeks of gestation) having done a necrotizing enterocolitis stage II or III according to Bell's criteria.
排除标准
- •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
结局指标
主要结局
Necrotizing enterocolitis (NEC)
时间窗: 10 years
Number of infants with NEC at a Bell stage \> 1 in Nancy as compared to Lyon
Risk factor of NEC during Pregnancy
时间窗: 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
时间窗: 10 years
Gestational age in weeks of infants presenting with NEC in Nancy as compared to Lyon
次要结局
- Red Blood Cell transfusion(10 years)
- Perinatal risk factor of NEC(10 years)
- NEC occurrence(10 years)
- Gender(10 years)
- Place of birth as risk factor for NEC(10 years)
- Asphyxia at birth(10 years)
- Patent Ductus Arteriosus (PDA)(10 years)
- Feeding(10 years)
- Infection(10 years)
研究者
Jean-Michel HASCOET
Professor
Central Hospital, Nancy, France