Nitric Oxide for Congenital Heart Defects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether nitric oxide can protect the brain and kidneys during heart surgery for babies under one year old with congenital heart defects. Researchers aim to determine if nitric oxide reduces brain stress and kidney damage post-surgery, potentially affecting ICU recovery time. The trial compares two groups: one receiving standard care and the other receiving nitric oxide during surgery. Babies with heart defects scheduled for corrective surgery, who do not require inhaled nitric oxide immediately before surgery, might be suitable candidates for this study. As a Phase 2, Phase 3 trial, this study evaluates the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering a chance to contribute to significant medical advancements.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that nitric oxide is generally safe for people with congenital heart conditions. One study found that using nitric oxide in adults with these heart conditions and high blood pressure in the lungs after surgery was safe and effective. However, another study found that nitric oxide did not help children recover faster after heart surgery.
These results suggest that while nitric oxide is usually well-tolerated, it may not always accelerate recovery. Participants should consider this when deciding to join the trial. In terms of safety, nitric oxide has proven to be a dependable option in similar treatments.12345Why do researchers think this study treatment might be promising for congenital heart defects?
Unlike the standard treatment options for congenital heart defects, which typically involve surgery and cardiopulmonary bypass procedures, the use of Nitric Oxide (NO) offers a novel approach. Nitric Oxide is unique because it acts as a vasodilator, helping to relax and widen blood vessels, which may improve blood flow during the critical phases of surgery. Researchers are excited about this treatment because it could potentially reduce complications and improve recovery times for patients undergoing heart surgery, thanks to its ability to better manage blood circulation during procedures. This represents a significant advancement, offering hope for safer and more effective surgical outcomes.
What evidence suggests that nitric oxide might be an effective treatment for congenital heart defects?
Studies have shown that nitric oxide can benefit patients with congenital heart defects by reducing heart and lung injuries during heart surgery. Research also indicates that nitric oxide can lower troponin levels, a marker of heart damage, after surgery. In this trial, participants in the nitric oxide group will receive Nitric Oxide (NO) during cardiopulmonary bypass, potentially protecting the heart and lungs and easing recovery. Meanwhile, the standard of care group will undergo the standard cardiopulmonary bypass procedure without nitric oxide.46789
Who Is on the Research Team?
David P Bichell, MD
Principal Investigator
Vanderbilt University Medical Center
Are You a Good Fit for This Trial?
This trial is for babies under 1 year old with congenital heart defects (CHD) who are scheduled for corrective surgery using cardiopulmonary bypass. It's not open to those needing emergency surgery, with severe developmental delays, pre-existing kidney disease, or a need for nitric oxide before surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo cardiopulmonary bypass with or without nitric oxide administration
ICU Monitoring
Participants are monitored in the ICU for delirium and organ dysfunction
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nitric Oxide (NO) 20 part per million (ppm)
Trial Overview
The study tests if inhaling low doses of Nitric Oxide (NO) can protect the brain and kidneys during heart surgery. Researchers will measure specific proteins and monitor patients' recovery in the ICU to see if NO makes a difference.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants in this group will receive Nitric Oxide (NO) while undergoing Cardiopulmonary bypass (CPB)
Participants in this group will receive standard of care
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
Published Research Related to This Trial
Citations
Statistical analysis plan for the NITric oxide during ...
Statistical analysis plan for the NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC) trial.
Effect of Nitric Oxide via Cardiopulmonary Bypass on ...
Studies have suggested that nitric oxide added to the gas inflow of the cardiopulmonary bypass oxygenator may decrease postoperative troponin ...
3.
cardiothoracicsurgery.biomedcentral.com
cardiothoracicsurgery.biomedcentral.com/articles/10.1186/s13019-024-02953-yImpact of nitric oxide via cardiopulmonary bypass on pediatric ...
In the past decade, numerous studies had reported that adding NO to the CPB circle can reduce heart and lung injuries [29, 30]. Additionally, it ...
Nitric Oxide for Congenital Heart Disease
Inhaled nitric oxide is an effective treatment for pulmonary hypertension in patients with congenital heart disease, particularly benefiting newborns, who made ...
Nitric Oxide During CPB to Reduce AKI in Neonates
Gestational age: 38 weeks; Diagnosis: Congenital Heart Disease (CHD); Planned surgery to include cardiopulmonary bypass (CPB )for underlying CHD; Consent of ...
Statistical analysis plan for the NITric oxide during ...
Statistical analysis plan for the NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC) trial.
7.
bmccardiovascdisord.biomedcentral.com
bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-025-04967-3Innovative nitric oxide delivery technology for postoperative ...
This device has proven to be safe and effective for use in adult patients with congenital heart disease and pulmonary hypertension post-surgery.
8.
innovationdistrict.childrensnational.org
innovationdistrict.childrensnational.org/jama-study-shows-no-benefit-to-nitric-oxide-in-cardiopulmonary-bypass-for-young-children/JAMA study shows no benefit to nitric oxide in ...
An international clinical trial showed that nitric oxide doesn't help kids recover faster from cardiac surgery with cardiopulmonary bypass.
Efficacy and Safety of Pulmonary Vasodilator and Inodilator ...
Vasodilators and inodilators did not significantly reduce perioperative mortality in paediatric CHD. Some agents, such as intravenous sildenafil ...
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