Prevention of Transfusion Related Acute Gut Injury (TRAGI) in Extremely Low Gestational Age Neonates (ELGAN) Neonates Using iNO
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Increased NIRS oxygenation after a PRBC transfusion in iNO treated neonates vs Placebo
研究概览
简要总结
The investigators seek to determine whether providing inhaled nitric oxide (iNO; a vasodilator) will improve the delivery of oxygen to the brain, kidney and intestines of preterm neonates during and after the subject receives a packed red blood cell transfusion (PRBC) for anemia vs. baseline period. The investigators will observe the effect of inhaled nitric oxide vs. placebo at these body sites to determine whether iNO will alter the fractional tissue oxygen extraction. Treatment and control groups will be compared to each other at equivalent epochs as will individual patients before, during and after the PRBC transfusion.
详细描述
Selection criteria: 1) Neonates 24 0/7 to 27 6/7 weeks gestational age (GA) 2) More than 2 weeks postnatal age. 3) Anemia with Hct less than 28 % 4) >50 % total daily fluids is enteral 5) History of at least 1 prior PRBC transfusion ELGANs admitted to the neonatal intensive care unit (NICU) will be screened for the study. If patients meet the selection criteria, parents will be approached to obtain informed consent. Then the patient will be randomized to either iNO or placebo group before treatment. The treating physician will make the decision regarding timing of the PRBC transfusion to treat anemia for the subject.
During the period of observation, near infrared spectroscopy (NIRS) monitoring will be performed on all enrolled subjects during which a non-invasive probe will be attached to the skin at 3 sites simultaneously- on abdomen below umbilicus, flank/back, and forehead for calculation of fractional tissue oxygen extraction ( FTOE) in conjunction with concurrent pulse oximetry recordings.
Conventional vital signs, blood gas, lactate, haptoglobin and cytokines will be measured before and after the PRBC transfusion
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
iNO vs nitrogen will be administered from tanks labeled with a code number that is known by the manufacturer and a campus safety officer but masked to investigators and to bedside personnel.
入排标准
- 年龄范围
- 2 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates 24 0/7 to 27 6/7 weeks gestational age
- •More than 2 weeks postnatal age.
- •Anemia with hematocrit (Hct) less than 28 %
- •More than 50 % total daily fluids is enteral
- •History of at least 1 prior PRBC transfusion (preferably same donor)
排除标准
- •Prior history of necrotizing enterocolitis (NEC) to avoid a confounder
- •Clinically significant patent ductus arteriosus (PDA) requiring treatment (Rx) within 24h
- •Hypotensive for age or active bleeding
- •< 50% of total fluids are enteral (breast milk or formula)
- •Major congenital or surgical malformations
- •Known chromosomal anomalies detected by antepartum testing or direct physical examination with subsequent postnatal laboratory confirmation
- •Absence of parental or treating physician consent
- •A concurrent randomized clinical trial (RCT) with another randomized drug
- •Death expected < 48h
- •Another major concern by the treating physician that either mandates or prohibits study treatment such as known adverse reaction to prior transfusion (Tx)
研究组 & 干预措施
Inhaled Nitric Oxide
iNO will be given at 20 ppm, continuous, via inhalation before (1 hour), during (3 hours) and after (2 hours) elective blood transfusion and NIRS monitoring
干预措施: Inhaled Nitric Oxide (Drug)
Placebo
Placebo gas (nitrogen) will be given continuous, via inhalation at the same ppm, before (1 hour), during (3 hours) and after (2 hours) elective blood transfusion and NIRS monitoring
干预措施: Placebo (Drug)
结局指标
主要结局
Increased NIRS oxygenation after a PRBC transfusion in iNO treated neonates vs Placebo
时间窗: 19 hours
The investigators hypothesize that NIRS signal will be significantly higher in the iNO treated group during the 2nd hour after transfusion is concluded vs Placebo. NIRS will be measured continuously and averaged every 5 minutes to create a single hourly point for each subject before and after the transfusion for statistical analysis.
次要结局
- Lower fractional tissue oxygen extraction (FTOE) in iNO treated neonates after PRBC transfusion vs Placebo(19 hours)
研究者
Edmund LaGamma
Chief of Neonatology
New York Medical College