The Impact of Different Feeding Strategies During Packed Red Cell Transfusion on Intestinal Oxygenation
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- mesenteric oxygenisation (number of participants that has low mesenteric oxygenisation after transfusion)
研究概览
简要总结
This study aims to compare the differences between three different feeding regimens on intestinal oxygenation during packed red blood cell (PRBC) transfusion in premature babies.
详细描述
Necrotizing enterocolitis is an important cause of mortality and morbidity in neonates. Especially neonates, who are smaller than 32 weeks of gestational, need transfusions during their hospital stay. Recent evidences suggest a relation between antecedent PRBC transfusions and an increase in necrotizing enterocolitis (NEC). It has been reported that transfusion related NEC (TR-NEC) tend to occur immediately and up to 48 hours post-transfusion. Although the underlying mechanism of this relationship is still overinvestigation, altered oxygenation of the mesenteric vasculature during PRBC transfusion has been hypothesized to contribute to NEC development. But pathophysiology of this has not been cleared, yet. Nowadays, due to the increased risk of NEC during PRBC transfusion, different nutrition protocols are implemented in different units. These protocols contain permanent discontinuation, reducement or continuation of nutrition during the transfusion. As a result, there is still no evidence -based practice recommendation in this regard.
"Restricted Transfusion Guidelines" will be used for the decision of transfusion in premature infants. Patients will be divided into three different groups, according to their feeding regimen during transfusion.
Group 1: No enteral feeding before (two hours), during (3 hours) and after (two hours) red blood cell transfusion.
Group 2: Enteral feeding is reduced by %50 before, during and after the red blood cell transfusion.
Group 3: The same feeding volume will be continued without decreasing or stopping.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- — 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prematurity (<32 completed weeks of gestation at birth)
- •Need for PRBC transfusion
- •Feeding at least 30ml/kg/day at the time of transfusion
排除标准
- •Neonates previously diagnosed with gastrointestinal problems such as NEC, intestinal perforation or atresia.
- •Infants receiving continuous feeds or less than 30ml/kg/day
- •Major congenital or chromosomal abnormalities or infants unlikely to survive
- •Intraventricular hemorrhage >Grade 3
- •Hemodynamically significant patent ductus arteriosus
- •Infants requiring vasopressor support
- •Skin disruption precluding application of sensors
结局指标
主要结局
mesenteric oxygenisation (number of participants that has low mesenteric oxygenisation after transfusion)
时间窗: 48 hours
number of participants that has low mesenteric oxygenisation after transfusion
次要结局
- Feeding intolerance (number of participants that has feeding intolerance after transfusion)(starting with transfusion until discharge, assessed up to 12 weeks)
- NEC (number of participants that has occurred transfusion related NEC)(starting with transfusion until discharge, assessed up to 12 weeks)