Clinical Trial: Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) in Pediatrics
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: The Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) In Pediatrics
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 Summary: 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.
Sponsor: Mallinckrodt
Current Primary Outcome: arterial blood gases [ Time Frame: baseline through 24 hours and extubation ]
Original Primary Outcome:
Current Secondary Outcome:
- methemoglobin [ Time Frame: baseline, hour 4 and 24 hours ]
- broncho-alveolar lavage fluid [ Time Frame: baseline, 48 hours and day 5 ]
- Prone position [ Time Frame: baseline then daily ]
Original Secondary Outcome:
Information By: Mallinckrodt
Dates:
Date Received: July 10, 2002
Date Started: January 2002
Date Completion:
Last Updated: July 22, 2016
Last Verified: July 2016
