Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) in Pediatrics
- Conditions
- AnoxemiaRespiratory Insufficiency
- Interventions
- Drug: inhaled nitric oxide
- Registration Number
- NCT00041561
- Lead Sponsor
- Mallinckrodt
- Brief Summary
The purpose of this study is to determine the effect of nitric oxide for inhalation on the duration of mechanical ventilation in pediatric patients with AHRF.
- Detailed Description
Patients will receive 5-ppm study gas (nitric oxide for inhalation or placebo) until Day 28 or extubation, whichever comes first. The following will be performed / recorded at specified times during the study: arterial blood gases, ventilator settings, methemoglobin, PRISM III score, and patient positioning. Selected centers will also be performing plasma cytokine assays, broncho-alveolar lavage fluid assays and a 6 month follow-up assessment.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 55
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Nitrogen gas Nitrogen gas 1 inhaled nitric oxide Inhaled Nitric Oxide
- Primary Outcome Measures
Name Time Method arterial blood gases baseline through 24 hours and extubation
- Secondary Outcome Measures
Name Time Method broncho-alveolar lavage fluid baseline, 48 hours and day 5 Prone position baseline then daily methemoglobin baseline, hour 4 and 24 hours
Trial Locations
- Locations (16)
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Chrildren's Hospital of Orange County
🇺🇸Orange, California, United States
Children's Healthcare of Atlanta at Egleston
🇺🇸Atlanta, Georgia, United States
Nemours Children's Clinic
🇺🇸Orlando, Florida, United States
The Children's Hospital
🇺🇸Denver, Colorado, United States
University of Chicago, Children's Hospital
🇺🇸Chicago, Illinois, United States
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
The Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Children's Hospital at Montefiore
🇺🇸Bronx, New York, United States
New York Presbyterian Hospital
🇺🇸New York, New York, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Children's Hospital
🇺🇸Columbus, Ohio, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
The Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Virginia Pediatric Critical Care
🇺🇸Charlottesville, Virginia, United States