~8 spots leftby Aug 2025

Nitric Oxide for Congenital Heart Defects

Palo Alto (17 mi)
Overseen byDavid P Bichell, MD
Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Waitlist Available
Sponsor: Vanderbilt University Medical Center
No Placebo Group
Prior Safety Data

Trial Summary

What is the purpose of this trial?The goals of this study are: 1. To evaluate the neuroprotective effect of nitric oxide by measuring glial fibrillary acid protein (GFAP) before and after surgery. GFAP will be analyzed via an enzyme-linked immunosorbent assay (ELISA) kit. Patients will also be monitored post-operatively for delirium in the intensive care unit (ICU). 2. To evaluate the renal protective effect of nitric oxide by measuring neutrophil gelatinase-associated lipocalin (NGAL) before and after surgery. NGAL will also be analyzed via an ELISA kit. Patient creatinine will be monitored post-operatively. 3. To evaluate effect of nitric oxide on other ICU outcomes (invasive mechanical ventilation, days to extubation, ICU and hospital length of stay, and blood product administration).

Eligibility Criteria

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

I am under 1 year old.
My baby is having heart surgery with a heart-lung machine.

Exclusion Criteria

I need inhaled nitric oxide right before surgery.
I have a kidney condition.
I require emergency surgery.

Treatment Details

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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Nitric oxide groupExperimental Treatment1 Intervention
Participants in this group will receive Nitric Oxide (NO) while undergoing Cardiopulmonary bypass (CPB)
Group II: Standard of care cardiopulmonary bypass procedureActive Control1 Intervention
Participants in this group will receive standard of care

Find a clinic near you

Research locations nearbySelect from list below to view details:
Vanderbilt University Medical CenterNashville, TN
Loading ...

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

References