Splanchnic Oxygenation in Response to Enteral Feeds Before and After Red Blood Cell Transfusion in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pre-transfusion splanchnic oxygenation pattern
研究概览
简要总结
Since 1987, red blood cell (RBC) transfusions have been proposed as a potential risk factor for necrotizing enterocolitis (NEC), which is one of the most severe gastrointestinal complications of prematurity.
Evidence from Doppler studies have shown a post-transfusion impairment of mesenteric blood flow in response to feeds, whereas NIRS studies have reported transient changes of splanchnic oxygenation after RBC transfusion; a possible role for these findings in increasing the risk for TANEC development has been hypothesized.
The aim of this study is to evaluate SrSO2 patterns in response to enteral feeding before and after transfusion.
详细描述
Premature neonates are among the most transfused population, but the risks and benefits of this procedure remain unclear. Since 1987, red blood cell (RBC) transfusions have been proposed as a potential risk factor for necrotizing enterocolitis (NEC), which is one of the most common and feared gastrointestinal complications of prematurity. Several observational studies have tried to demonstrate this causal correlation, defining the so-called transfusion-associated NEC (TANEC), which occurs within 48 hours after RBC transfusion.
Evidence from Doppler studies have shown a post-transfusion impairment of mesenteric blood flow in response to feeds, whereas NIRS studies have reported transient changes of splanchnic oxygenation after RBC transfusion. This evidence, which has been hypothesized to play a role on the risk of TANEC development, has significantly raised the attention over the feeding plans during and after RBC transfusion.
To date, splanchnic oxygenation response to feeds before and after transfusion has not been investigated, but could bring useful information to understand the splanchnic hemodynamic changes associated to RBC transfusion.
Therefore, the aim of this study is to evaluate SrSO2 patterns in response to enteral feeding before and after transfusion.
Enrolled infants will undergo a 12-h monitoring of cerebral (CrSO2) and splanchnic (SrSO2) oxygenation, performed using an INVOS 5100 oxymeter (Medtronic, Boulder, CO), whose neonatal sensors will be placed in the central region of the forehead and the below the umbilicus, respectively.
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
- 否
入选标准
- •gestational age <32 weeks or birth weight <1500 g
- •need for red blood cell transfusion according to national guidelines
排除标准
- •hemodynamic instability
- •Prior occurrence of necrotizing or presence of symptoms and signs of feeding intolerance within one week before transfusion
结局指标
主要结局
Pre-transfusion splanchnic oxygenation pattern
时间窗: Enteral feed before red blood cell transfusion administration (3 hours)
Decrease or increase of splanchnic oxygenation during and after feed administration compared to pre-prandial baseline value
Post-transfusion splanchnic oxygenation pattern
时间窗: Enteral feed after red blood cell transfusion administration (3 hours)
Decrease or increase of splanchnic oxygenation during and after feed administration compared to pre-prandial baseline value
次要结局
- Incidence of gut complications(48 hours after transfusion)
研究者
Luigi Corvaglia
Associate Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna