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NO During CPB in Neonates to Reduce Risk of AKI

Efficacy of Nitric Oxide Administration During Cardiopulmonary Bypass in Neonates at Reducing the Risk of Acute Kidney Injury

Who can join

1 Day – 31 Days · All sexes

Inclusion Criteria:

* All neonates (≤31 days) undergoing cardiac surgery with CPB for CHD will be deemed eligible for enrollment.

Exclusion Criteria:

1. Failure to obtain informed consent from parent/guardian
2. Clinical signs of preoperative persistent elevated pulmonary vascular resistance,
3. Emergency surgery,
4. Episode of cardiac arrest within 1 week before surgery,
5. Recent treatment with steroids and/or a condition that may require treatment with steroids (excluding steroid administration specifically for CPB),
6. Use of inhaled NO (iNO) immediately prior to surgery,
7. Structural renal abnormalities by ultrasound,
8. Preoperative AKI,
9. Use of other investigational drugs,
10. Weight less than \<2 kg,
11. Gestational age \<36 weeks,
12. Major extracardiac congenital anomalies,
13. Non-English speakers.

About the study

Acute kidney injury (AKI) following cardiac surgery for congenital heart defects (CHD) in children affects up to 60% of high risk-patients and is a major cause of both short- and long-term morbidity and mortality. Despite effort, to date, no successful therapeutic agent has gained widespread success in preventing this postoperative decline in renal function. Nitric oxide is an intricate regulator of acute inflammation and coagulation and is a potent vasodilator. The investigators hypothesize that nitric oxide, administered during cardiopulmonary bypass (CPB), may reduce the incidence of AKI.

What is being tested

• Nitric Oxide (drug)
• Oxygen (drug)

Sponsor: Children's Hospital Medical Center, Cincinnati · Participants: 40 · Started: Jan 10, 2023

Contact the study team

• David S Cooepr, MD · Phone: 5138035448

Official record on ClinicalTrials.gov — NCT04216927

Locations in the U.S.

Conditions

• Congenital Heart Defects

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.