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Vasodilator

Nitric Oxide for Congenital Heart Defects

Phase 2 & 3
Waitlist Available
Led By David P Bichell, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age <1 year old
Neonates and infants with CHD undergoing CPB for corrective surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date of admission to date of hospital discharge and/or 90 days post operation (approximately 90 days)
Awards & highlights

Study Summary

This trial will evaluate the neuro- and renal-protective effects of nitric oxide in patients undergoing surgery. GFAP and NGAL will be measured before and after surgery, and patients will be monitored for delirium, length of stay, and other outcomes.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the summary doesn't specify side effects, generally inhaling nitric oxide may cause issues like methemoglobinemia (a blood disorder), airway inflammation, or increased bleeding risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am under 1 year old.
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My baby is having heart surgery with a heart-lung machine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date of admission to date of hospital discharge and/or 90 days post operation (approximately 90 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and date of admission to date of hospital discharge and/or 90 days post operation (approximately 90 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Level of glial fibrillary acid protein (GFAP)
Level of neutrophil gelatinase-associated lipocalin (NGAL)
Secondary outcome measures
Daily prevalence of delirium as measured by preschool confusion assessment method for the ICU (psCAM-ICU)
Duration of mechanical ventilation
Functional Status
+4 more

Trial Design

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 Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,142 Total Patients Enrolled
David P Bichell, MDPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials

Media Library

Nitric Oxide (NO) 20 part per million (ppm) (Vasodilator) Clinical Trial Eligibility Overview. Trial Name: NCT05101746 — Phase 2 & 3
Congenital Heart Disease Research Study Groups: Standard of care cardiopulmonary bypass procedure, Nitric oxide group
Congenital Heart Disease Clinical Trial 2023: Nitric Oxide (NO) 20 part per million (ppm) Highlights & Side Effects. Trial Name: NCT05101746 — Phase 2 & 3
Nitric Oxide (NO) 20 part per million (ppm) (Vasodilator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05101746 — Phase 2 & 3

Frequently Asked Questions

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

Is NO 20 ppm a common choice for other scientific research studies of this type?

"There are 24 ongoing studies related to Nitric Oxide (NO) 20 part per million (ppm), 9 of which are in Phase 3. The largest number of these clinical trials are taking place in Anchorage, Alaska, but there are a total of 116 locations running trials for Nitric Oxide (NO) 20 part per million (ppm)."

Answered by AI

What is the total patient number for this clinical trial?

"Currently, this clinical trial is not recruiting any more participants. The trial dates back to April 25th, 2022 and has not been updated since then. There are other, similar trials that may be of interest. For example, there are 359 trials for heart-related issues and 24 for Nitric Oxide (NO) 20 part per million (ppm) that are actively recruiting participants."

Answered by AI

Is this study only recruiting patients that are 65 years or older?

"This study is looking for test subjects who have not celebrated their first birthday yet."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Nitric Oxide Effect on Brain and Kidney in Pediatric Patients Undergoing Cardiopulmonary Bypass
David Bichell 2022. "Nitric Oxide Effect on Brain and Kidney in Pediatric Patients Undergoing Cardiopulmonary Bypass". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05101746.
~10 spots leftby Nov 2024
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