Prevention of Transfusion Related Acute Gut Injury (TRAGI) in Extremely Low Gestational Age Neonates (ELGANs) Using iNO

• Status: Unknown status
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York Medical College
• Collaborators: Baystate Medical Center; East Carolina University; New York University; Stony Brook University
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)