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Nitric Oxide for Congenital Heart Disease

Phase 3
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All neonates (≤31 days) undergoing cardiac surgery with CPB for CHD will be deemed eligible for enrollment.
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights

Study Summary

This trial is testing whether nitric oxide can prevent acute kidney injury in children undergoing surgery for congenital heart defects.

Who is the study for?
This trial is for newborns (up to 31 days old) who need heart surgery with cardiopulmonary bypass for congenital heart defects. They must weigh over 2 kg and be at least 36 weeks gestational age. Babies can't join if they've had a recent cardiac arrest, preoperative AKI, certain lung or kidney conditions, steroid treatments, or are on other trials.Check my eligibility
What is being tested?
The study tests whether nitric oxide given during heart surgery can lower the risk of acute kidney injury in newborns with congenital heart defects. It's exploring if this gas helps protect the kidneys by reducing inflammation and improving blood flow during surgery.See study design
What are the potential side effects?
Nitric oxide may cause low blood pressure due to its vessel-widening effects, breathing difficulties if it affects oxygen levels in the blood, and possibly increase bleeding risks because of its effect on clotting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My newborn is having heart surgery with CPB for congenital heart disease.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Secondary outcome measures
Biomarker evidence of AKI - IL-18
Biomarker evidence of AKI - KIM-1
Biomarker evidence of AKI - L-FABP
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nitric OxideExperimental Treatment1 Intervention
Intraoperative NO entrained at 20 ppm into the oxygenator of the CPB circuit with standard care
Group II: OxygenPlacebo Group1 Intervention
Standard CPB without NO administered at any point intraoperatively
First Studied
Drug Approval Stage
How many patients have taken this drug
Nitric Oxide
Completed Phase 4

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,557 Total Patients Enrolled
MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
16,188 Total Patients Enrolled
Indiana UniversityOTHER
980 Previous Clinical Trials
983,120 Total Patients Enrolled

Media Library

Nitric Oxide (Vasodilator) Clinical Trial Eligibility Overview. Trial Name: NCT04216927 — Phase 3
Congenital Heart Disease Research Study Groups: Oxygen, Nitric Oxide
Congenital Heart Disease Clinical Trial 2023: Nitric Oxide Highlights & Side Effects. Trial Name: NCT04216927 — Phase 3
Nitric Oxide (Vasodilator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04216927 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

When is Nitric Oxide supplementation most useful?

"Hypoxemia, respiratory failure, and anemia can all be mitigated by using Nitric Oxide."

Answered by AI

What other types of research has been conducted with Nitric Oxide?

"As of now, 47 clinical trials that are studying Nitric Oxide are still active. Out of these47 trials, 18 have progressed to Phase 3 testing. Most of the research being conducted for Nitric oxide is located in Peradeniya, Ontario; however, there are a total 153 centres running these sorts of trials."

Answered by AI

What is the trial's recruitment goal?

"Unfortunately, this study is not looking for new recruits at the moment. It was originally posted on September 30th 2022 but was last updated on August 23rd of the same year. There are 633 other trials actively recruiting patients with kidney problems and 47 for Nitric Oxide if you're interested in participating in other studies."

Answered by AI

Would subjects outside of the target age range be able to enroll in this trial?

"This particular trial is only seeking patients that are between 1 day and 31 days old. Out of the 730 total clinical trials, this one is for a particularly young age group. 142 cater to people under 18 years old and 568 serve those over 65."

Answered by AI

Are there currently any openings for this clinical research?

"Although this study is no longer recruiting, it was last updated on 8/23/2022. If you are interested in finding other trials, 633 studies concerning kidney patients and 47 involving Nitric Oxide are currently enrolling patients."

Answered by AI
~14 spots leftby Dec 2024