Using nitric oxide during heart surgery in newborns to prevent kidney injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of nitric oxide during cardiopulmonary bypass in neonates undergoing cardiac surgery for congenital heart disease. The study aims to determine if administering nitric oxide can reduce the incidence of acute kidney injury, a common complication affecting up to 60% of high-risk patients post-surgery. By targeting the inflammatory and coagulation pathways, the researchers hope to improve renal outcomes in this vulnerable population. The trial is interventional and is currently in Phase 3.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Study coordinator: David S Cooepr, MD
• Email: David.Cooper@cchmc.org
• Phone: 5138035448

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.