Actively Recruiting
Efficacy of Nitric Oxide During Cardiopulmonary Bypass in Neonates to Reduce Risk of Acute Kidney Injury
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-07-24
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
M
Mallinckrodt
Collaborating Sponsor
AI-Summary
What this Trial Is About
Acute kidney injury (AKI) often occurs in children after heart surgery for congenital heart defects (CHD), affecting up to 60% of high-risk patients and leading to serious health problems. Researchers are studying whether giving nitric oxide during cardiopulmonary bypass (CPB) can lower the chance of AKI. This is a Phase 3 clinical trial sponsored by Children's Hospital Medical Center, Cincinnati. Participants are newborns up to 31 days old who undergo cardiac surgery with CPB. They will be randomly assigned to receive either nitric oxide at 20 ppm delivered through the oxygenator during surgery or standard CPB care without nitric oxide. The study compares these two approaches to see if nitric oxide helps prevent AKI. During the study, patients will be monitored closely with tests measuring kidney injury markers and kidney function for 72 hours after surgery. Researchers will track outcomes like AKI occurrence, biomarkers such as NGAL and KIM-1, and cardiac function. The total participation involves the surgery and follow-up assessments within the first three days after the operation.
CONDITIONS
Brief Title
NO During CPB in Neonates to Reduce Risk of AKI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonates aged 31 days or younger undergoing cardiac surgery with cardiopulmonary bypass for congenital heart disease
You will not qualify if you...
- Failure to obtain informed consent from parent or guardian
- Presence of persistent high pulmonary vascular resistance before surgery
- Emergency surgery cases
- Cardiac arrest episode within 1 week before surgery
- Recent steroid treatment or conditions requiring steroids (except steroids for CPB)
- Use of inhaled nitric oxide immediately before surgery
- Structural kidney abnormalities seen on ultrasound
- Preoperative acute kidney injury
- Use of other investigational drugs
- Weight less than 2 kilograms
- Gestational age under 36 weeks
- Major congenital anomalies outside the heart
- Non-English speakers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During surgery
Participants receive intraoperative nitric oxide or oxygen during cardiopulmonary bypass as part of their cardiac surgery.
1 intraoperative treatment session
Duration - Up to 72 hours post-surgery
Participants are monitored for acute kidney injury and other outcomes within 72 hours after surgery.
Approximately 3 visits in the 72 hours after surgery
Trial Site Locations
Total: 1 location
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
D
David S Cooepr, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
2
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