Non-Invasive Prediction of Necrotizing Enterocolitis in Preterm Neonates with Feeding Intolerance
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Electrical cardiometry for prediction of NEC in preterm neonates with feeding intolerance
研究概览
简要总结
Prospective observational study to evaluate the efficiency of using electrical cardiometry in combination with fecal lipocalin-2 for prediction of NEC in preterm neonates with feeding intolerance
详细描述
Necrotizing enterocolitis is one of the most life-threatening conditions for premature infants in neonatal intensive care units (NICU) and is associated with severe intestinal inflammation and necrosis, which occurs in 5-16% of very low birth weight (VLBW) infants with a mortality rate of 20-50% and various long-term clinical sequelae for the survivors.
Although preterm intestinal epithelium is suggested to be predisposed to an exaggerated inflammatory response to the present microbiome, impaired mesenteric perfusion inducing bowel hypoxia and ischemia is suggested to be one of the factors playing a major role in the development of NEC.
Pathogenesis of NEC is multifactorial; however, one of the major factors is the disturbance in the end-organ blood flow with early hypoperfusion and hypotension, predisposing for developing NEC in preterm neonates.
Electrical cardiometry (EC) is an impedance-based method that has been introduced for continuous noninvasive hemodynamic monitoring for cardiac output (CO) and DO2 in both term and preterm infants.
Clinical studies have shown that abnormal perfusion in the splanchnic circulation, particularly in the superior mesenteric artery (SMA), may have a role in the development of NEC in newborns so can be used for early diagnosis and evaluation of NEC progression.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 28 Days(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm neonates with gestational age ≤ 35 weeks, admitted to NICU, started enteral feeding and diagnosed as having feeding intolerance defined as stage IA and IB by modified bell's staging
排除标准
- •Chromosomal anomaly or multiple congenital malformations.
- •Patient with surgical malformation of the intestinal tract (i.e. omphalocele, gastroschisis, malrotation, intestinal atresia)
- •Patient diagnosed as hypoxic ischemic encephalopathy.
结局指标
主要结局
Electrical cardiometry for prediction of NEC in preterm neonates with feeding intolerance
时间窗: 48 hours
low cardiac output measured by electrical cardiometry predict NEC in preterm with feeding intolerance
次要结局
- Fecal lipocalin-2 for prediction of NEC in preterm neonates with feeding intolerance(48 hours)
- SMA flow in prediction of NEC in preterm neonates with feeding intolerance(48 hours)
研究者
Mohamed Sayed Hassan
assistant lecturer
Ain Shams University
