Impact of Enteral Feeding on Cerebral and Splanchnic Oxygenation During Packed Red Blood Cell Transfusion in Preterm Infants: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Splanchnic oxygenation
研究概览
简要总结
This clinical trial aims to learn if enteral feeding influences cerebral and splanchnic oxygenation during red blood cell infusion in very low birth-weight preterm infants. It will also learn about how continuing or withholding enteral feeding during blood transfusion might trigger transfusion-related necrotizing enterocolitis. The main questions, it aims to answer are:
- Does continuing or withholding enteral feeding have any impact on splanchnic and cerebral oxygenation in very-low-birth-weight preterm infants?
- Does continuing enteral feeding result in feeding intolerance during red blood cell infusion or transfusion-related necrotizing enterocolitis (TANEC) in very-low-birth-weight preterm infants? Researchers will compare regional cerebral and splanchnic oxygenation obtained by Near Infra-Red Spectroscopy (NIRS) monitoring while receiving red blood cell transfusion.
Participants will:
- Continue or withhold enteral feeding during red blood cell infusion, and all participants will be under NIRS monitoring for the following 48 hours after the blood transfusion.
- Be monitored for any signs and symptoms of new-onset feeding intolerance and/or necrotizing enterocolitis for 48 hours following the blood transfusion
详细描述
Continuing enteral feeding during red blood cell transfusion can have a negative impact on cerebral and splanchnic oxygenation and trigger transfusion-related necrotizing enterocolitis (TANEC) in very low birth-weight infants of gestational age less than 32 weeks and/or birthweight less than 1500 grams. However, the issue of continuing or withholding enteral feeding to prevent TANEC in these neonates is a matter of debate. Enteral feeding is often withheld during blood transfusion to prevent TANEC.
This study was carried out to investigate the effect of enteral feeding during red blood cell infusion on cerebral and splanchnic oxygenation in low-birth-weight preterm infants. Secondary hypothesis was to observe (if any) the signs and symptoms of a new-onset feeding intolerance and/or necrotizing enterocolitis for 48 hours following the blood transfusion.
Enteral feeding will continue or be withhold in very low birthweight neonates during packed red blood cell transfusion. Regional cerebral and splanchnic oxygenation were measured using near-infrared spectroscopy (NIRS) for 48 hours.
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
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants with gestational age ≤32 weeks and/or birthweight ≤1500 gr,
- •survival at least the first week of life
- •being able to tolerate a minimum total daily feeding volume of 100 mL/kg/day,
- •hemodynamically stable infant (no need of inotropic support)
- •receiving packed red blood cell transfusion for the treatment of anemia of prematurity
- •Exclusion criteria:
- •feeding intolerance
- •newly or previously diagnosed stage II and greater necrotizing enterocolitis
- •spontaneous intestinal perforation
- •suspected / proven sepsis in the previous 72 hours
- •neonates in need of high-frequency oscillated ventilation support,
- •previous PRBC transfusions due to iatrogenic anemia, hemolysis and/or intraventricular hemorrhage to avoid sensitization by blood products,
- •hemodynamically significant patent ductus arteriosus
- •history of abdominal surgery,
- •complex congenital anomalies involving gastrointestinal tract and cardiovascular system,
- •missing data,
- •parental reluctance to consent.
排除标准
- 未提供
结局指标
主要结局
Splanchnic oxygenation
时间窗: Prior to red blood cell transfusion to 48 hours following blood transfusion
Monitoring regional splanchnic oxygenation (SrSO2) and splanchnic fractionated tissue oxygen saturation (sFTOE)
Cerebral oxygenation
时间窗: Prior to red blood cell transfusion to 48 hours following blood transfusion
Monitoring Cerebral oxygenation parameters, including cerebral regional oxygen saturation (crSO2), cerebral fractionated tissue oxygen saturation (cFTOE)
次要结局
- Feeding intolerance and/or transfusion related necrotizing enterocolitis(Prior to red blood cell transfusion to 48 hours following blood transfusion)
研究者
Hakan Ongun
Associate professor in neonatology
Akdeniz University