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临床试验/NCT04344639
NCT04344639已完成不适用

Incidence, Risk Factors, Severity and Prognosis of Necrotizing Enterocolitis in Turkey: A Prospective Multicentre Study

Turkish Neonatal Society2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年3月1日最近更新:
适应症

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

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

发起方
Turkish Neonatal Society
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tolga Hasan Çelik, MD

M.D., Assist. Prof., Division of Neonatology, Department of Pediatrics

Hacettepe University

研究点 (2)

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