Impact of Red Cell Transfusion on Superior Mesenteric Artery Flow Patterns and Intestinal Oxygenation in Fed Preterm Neonates (SPARTAN: Sma PAttern Related to TrAnsfusion in Neonates)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Post-prandial SMA flows changes before and after PRBC transfusion
研究概览
简要总结
This study aims to measure the changes induced by packed red blood cell (PRBC) transfusion in the superior mesenteric artery (SMA) flow velocity and intestinal oxygenation indices in premature neonates. These changes will be measured in relation to feeding, before and after a blood transfusion. Overall reduction of intestinal perfusion is a risk factor for necrotizing enterocolitis (NEC) - a condition with significant mortality and long term morbidity. Identifying specific patterns of flow velocity and tissue oxygenation changes will allow for planning, studying and implementing risk avoidance and minimization strategies.
详细描述
Hypothesis
In preterm neonates the anticipated physiologic post-prandial increase in each SMA flow and intestinal perfusion is blunted post transfusion. This is worse in SGA infants and/or in the presence of a PDA.
Questions: 1) Does PRBC transfusion alter postprandial SMA flow increases and intestinal oxygenation indices in preterm infants receiving enteral feeds? 2) Is there a difference in postprandial SMA flow and intestinal perfusion changes in recently transfused SGA infants compared to AGA infants, and in those with and without a PDA? Primary Outcome: Post-prandial SMA flows changes before and after PRBC transfusion.
Secondary outcomes: Pre-post prandial changes in near-infrared spectroscopy (NIRS)-measured intestinal oxygenation parameters before and after PRBC transfusion.
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 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prematurity (<34 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
- •Skin disruption precluding application of sensors
结局指标
主要结局
Post-prandial SMA flows changes before and after PRBC transfusion
时间窗: Just prior to transfusion until 48 hours post completion of transfusion
次要结局
未报告次要终点
研究者
Amelie Stritzke
MD
University of Calgary