Nitric Oxide During Heart Surgery in Newborns to Reduce Kidney Injury

This study is looking at whether giving Nitric Oxide during heart surgery for congenital heart disease (CHD) in newborns can reduce the risk of acute kidney injury (AKI). AKI is a serious problem that can happen after heart surgery in babies. Researchers believe Nitric Oxide, a gas that helps widen blood vessels, might help prevent this. You may be eligible if your baby is 31 days old or younger and needs heart surgery with a heart-lung machine (cardiopulmonary bypass or CPB) for CHD. The study will compare babies who receive Nitric Oxide to those who receive only Oxygen during surgery. The main goal is to see if Nitric Oxide reduces the number of babies who develop AKI within 72 hours after surgery. The study plans to enroll 40 babies.

Study design
This study is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 40 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, acute kidney injury, is measured at 72 hours after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04216927

NO During CPB in Neonates to Reduce Risk of AKI

Recruiting
PHASE3Ages 1–31InterventionalPrevention
Children's Hospital Medical Center, Cincinnati
~40 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Nitric OxideOxygen

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
AKI
Measured over 72 hours
AKI
CHD - Congenital Heart Disease
Surgery

NCT04216927

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

All neonates (≤31 days) undergoing cardiac surgery with CPB for CHD will be deemed eligible for enrollment.
  • AKI72 hours

    Incidence of AKI in the first 72 hours postoperative as defined by the Kidney Disease Improving Global Outcomes (KDIGO) diagnostic classification