Prevention of Transfusion Related Acute Gut Injury (TRAGI) in Extremely Low Gestational Age Neonates (ELGANs) Using iNO (iNO-TRAGI)
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.
This research study is led by Dr. Rachana Singh, 413-794-2400.
February 06, 2019
Baystate Medical Center, 759 Chestnut St, Springfield, MA
Ages Eligible for Study: Child, Adult, Older Adult
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
- Neonates 24 0/7 to 27 6/7 weeks gestational 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)
- 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
Interventional (Clinical Trial), Randomized