The primary purpose of this study is to compare the number of participants with reversible pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as compared to 100% oxygen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
136
Nitric Oxide (NO) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
100% oxygen (O2) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
Nitric Oxide (NO) for inhalation plus oxygen, given at 80ppm over 10 minutes using an INOvent® delivery system
Lucile Salter Packard Children's Hospital at Stanford
Stanford, California, United States
The Children's Hospital
Denver, Colorado, United States
Number of Participants With Reversible Pulmonary Hypertension (Vasoreactivity)
A composite of hemodynamic measurements were used to identify reversible pulmonary hypertension (vasoreactivity)
Time frame: on Day 1
Number of Participants With Related Surgical Procedures Within 1 Year
Number of participants who received surgery for pulmonary or cardiac disease within 1 year after treatment.
Time frame: within 1 year
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence. An AE need not have a causal relationship with treatment and included any event that was not seen at baseline or, if present at baseline, increased in severity.
Time frame: on Day 1
Number of Participants With Serious Adverse Events (SAEs)
SAEs were collected during the 12 hours after discontinuation of gas or discharge (whichever came first). An SAE was defined as any event that resulted in death, was life threatening, resulted in permanent disability or incapacity, required or prolonged inpatient hospitalization, or was a congenital anomaly. Important medical events that, without medical or surgical intervention, would also have resulted in one of the outcomes listed above were also considered as SAEs.
Time frame: within 12 hours
Number of Participants With Related Surgical Procedures Within 3 Years
Number of participants who received surgery related to pulmonary or cardiac disease within 3 years
Time frame: within 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Children's Hospital Boston
Boston, Massachusetts, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
New York Presbyterian Hospital
New York, New York, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Columbus Children's Hospital
Columbus, Ohio, United States
The Medical University of South Carolina
Charleston, South Carolina, United States
CHU Timone - Département de cardiologie
Marseille, France
Hôpital d'Enfants
Nancy, France
...and 8 more locations