The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants
The Effect of Packed Red Blood Cell Transfusion on Superior Mesenteric Artery Blood Flow Velocity in Premature Infants After Feeding
研究概览
详细说明
Currently a disparity exists among the NICU staff at Magee-Womens Hospital regarding whether premature infants should be fed during a blood transfusion. The effects of a blood transfusion on superior mesenteric artery blood flow velocity and the post-prandial hyperemia are not known.
We hypothesize that the post-prandial change in mesenteric blood flow velocity (BFV) will be the same before as after a packed red blood cell (PRBC) transfusion among anemic premature infants.
Sixty anemic infants (25-32 weeks GA, feeding >= 60 cc/kg/day) will undergo pre- and post-feed superior mesenteric artery Doppler studies both before and after a blood transfusion. Infants will be stratified by current weight into two groups (< 1250 grams and > 1250 grams). In each weight stratum the infants will be randomized to feeding or NPO during the PRBC transfusion. Randomization will be by block design, with block sizes ranging from two to six infants. The investigator performing the Doppler studies will remain masked to the feeding assignment of the infant.
The primary outcome for the study is the superior mesenteric artery blood flow velocity response to feeding between anemic and non-anemic states among premature infants. Our secondary outcome is the effect of feeding on BFV between anemic and non-anemic states in these infants. Statistical analysis will include paired and unpaired Student t-tests and regression analysis.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15213
- Magee-Womens Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Singleton infants born at 25-32 weeks gestation who are < 38 weeks post-conceptual age at enrollment
- First infant of twin gestation born at 25-32 weeks gestation who requires a blood transfusion; if both infants require transfusion on the same day the larger infant will be enrolled.
- Receiving bolus enteral feeds [PO (bottle) and/or PE (feeding tube)] of at least 60 cc/kg/day
- A planned packed red blood cell transfusion, as per the clinical team, for anemia
- Infant is very likely to require a blood transfusion according to the attending neonatologist.
Exclusion Criteria:
- Known congenital anomalies of the heart, brain, kidneys or intestine
- Chromosomal abnormality
- Intrauterine growth restriction at < 3% for weight at birth since this has been shown to alter mesenteric BFV and the post-prandial hyperemia
- Twin to twin transfusion sequence
- Higher order multiples
- Patent ductus arteriosus known to be present or currently being treated
- History of definite necrotizing enterocolitis Bell Stage 2 or greater
- Concurrent treatments with antibiotics or steroids
- Feeding intolerance, defined as gastric aspirate > 30% of feed volume on 3 sequential feeds
- Concurrent enrollment in another randomized trial
- Infants discharged or transferred to another facility without having received a PRBC transfusion will be excluded post-hoc.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：group 1
All babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be NPO during the PRBC transfusion
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有源比较器：group 2
Babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion
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babies receiving the intervention are fed during the PRBC transfusion
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无干预：group 3
All babies >1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion
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实验性的：group 4
All babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion
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babies receiving the intervention are fed during the PRBC transfusion
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Superior Mesenteric Artery Blood Flow Velocity From Pre-to-post Feed in the Anemic and the Transfused States
大体时间：1 hour
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Time-averaged mean and Peak systolic Doppler blood flow velocity in the mesenteric artery was measured before and after a feed when the baby was anemic (pre-PRBC transfusion) and then again when the baby was immediately post-transfusion
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1 hour
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合作者和调查者
调查人员
- 首席研究员：Gretchen Krimmel, MD、University of Pittsburgh
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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早产儿贫血的临床试验
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Swansea University完全的
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Scripps Translational Science Institute完全的