Nitric Oxide Effect on Brain and Kidney in Pediatric Patients Undergoing Cardiopulmonary Bypass
Key facts
- Where
- Nashville, United StatesSee the site
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 0 and 1 years old?
Source: NCT05101746, who can take part
Where in United States
- Vanderbilt University Medical CenterNashville, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Vanderbilt University Medical Center
- Trial code
- NCT05101746
- Record updated
- 8 October 2025
- Original description
The goals of this study are:Read full original descriptionShow less
Nitric Oxide Administration During Pediatric Cardiopulmonary Bypass Effects on End Organ Damage to the Brain and Kidney
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).
Inclusion: Neonates and infants with CHD undergoing CPB for corrective surgery; Age <1 year old.
Exclusion: Requirement of inhaled NO immediately prior to surgery; Emergency surgery; Severe developmental delay at baseline defined as a score of ≥ 4 (severe disability) on the Pediatric Cerebral Performance Category (PCPC) Scale, referencing cognitive status prior to critical illness; Pre-existing renal disease; Inability to understand English or deafness that will preclude delirium evaluation. The inability to understand English in verbal participants will not result in exclusion when the research staff is proficient and/or translation services are actively available in that particular language.