Prevention of Transfusion Related Acute Gut Injury (TRAGI) in Extremely Low Gestational Age Neonates (ELGANs) Using iNO
Status unconfirmed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Anemia
In brief
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.
Key facts
- Study ID
- NCT02851472
- Run by
- New York Medical College
- People needed
- 50
- Starts
- 2019-02-06
- Expected to finish
- 2021-06-30
- Last updated by the study team
- 2019-04-24
Who can join
Age: 0 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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)
Where it is running
- Baystate Children's Hospital — Springfield, Massachusetts, United States (enrolling)
- Maria Fareri Childrens Hospital — Valhalla, New York, United States (enrolling)
- East Carolina University — Greenville, North Carolina, United States (enrolling)
- Stony Brook Children's Hospital — Stony Brook, New York, United States
Full record on ClinicalTrials.gov
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