Incidence, Risk Factors, Severity and Prognosis of Necrotizing Enterocolitis in Turkey: A Prospective Multicentre Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Incidence of Necrotizing Enterocolitis
研究概览
简要总结
Necrotizing enterocolitis (NEC) is a gastrointestinal system disease characterized by inflammatory necrosis of the intestine mainly seen in premature infants, and continues to be an important cause of mortality and morbidity in neonatal intensive care units all over the world. Although it is more common in premature infants, it is also seen in term babies when the intestine is ischemic. Although the major problem in premature babies is the immaturity of the intestine, many factors contributing to immaturity play a role in the pathogenesis of NEC.
详细描述
Necrotizing enterocolitis (NEC) is a gastrointestinal system disease characterized by inflammatory necrosis of the intestine mainly seen in premature infants, and continues to be an important cause of mortality and morbidity in neonatal intensive care units all over the world. Although it is more common in premature infants, it is also seen in term babies when the intestine is ischemic. Although the major problem in premature babies is the immaturity of the intestine, many factors contributing to immaturity play a role in the pathogenesis of NEC.
With this study project, which is planned as a national multicenter prospective study, the incidence of necrotizing enterocolitis in newborn infants born in neonatal intensive care units in our country and the risk factors associated with the NEC, especially the detailed feeding history of the patient (when the first feeding is nourished, antibiotics and other treatments that are being used). Most epidemiological data such as the most common stage of the disease, treatment, prognosis, comparison with the data of other countries will provide important information for the neonatal health of our country.
The aim of this study was to determine the factors affecting the emergence of NEC in neonatal intensive care units and to determine the frequency of NEC.
Study Hypothesis: Delayed enteral feeding, intensive use of antibiotics and nutrients other than breast milk increase the incidence of necrotizing enterocolitis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 3 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns diagnosed with NEC in neonatal intensive care units
排除标准
- •Major congenital anomaly,
- •congenital heart disease (except for atrial septal defect, ventricular septal defect, patent ductus arteriosus)
- •Chromosomal anomaly
- •Inherited metabolic disease
- •Hypoxic ischemic encephalopathy
- •Newborns who died within the first 48 hours of life
结局指标
主要结局
Incidence of Necrotizing Enterocolitis
时间窗: 1 year
Incidence: frequency of NEC during study period
Initiation of enteral feeding time, choice of breastfeeding or formula
时间窗: 1 year
nutrition: breastfeeding of formula, delayed enteral feeding
Risk factors for mild and severe necrotizing enterocolitis
时间窗: 1 year
erytrocyte/FFP/trombocyte transfusions,PDA closing therapy, umbilical artery catheterisation,
Meconium discharge time
时间窗: 1 year
meconium discharge time (hour)
probiotic usage
时间窗: 1 year
probiotic usage, type of probiotic preparation
severity of necrotizing enrerocolitis
时间窗: 1 year
Grade of NEC disease according to modified Bell Criteria
次要结局
- Prognosis(1 year)
研究者
Tolga Hasan Çelik, MD
M.D., Assist. Prof., Division of Neonatology, Department of Pediatrics
Hacettepe University
