NCT00041561

Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) in Pediatrics

The Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) In Pediatrics

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Insufficiency
• Anoxemia

Interventions

Type	Name	Description
DRUG	Nitrogen gas	Nitrogen gas will be given at 5ppm until Day 28 or extubation
DRUG	inhaled nitric oxide	inhaled nitric oxide will be given at 5 ppm until day 28 or extubation

Timeline

• Start date: 2002-01-01
• Primary completion: 2004-12-01
• Completion: 2004-12-01
• First posted: 2002-07-11
• Last updated: 2016-07-26

Locations

16 sites across 1 country: United States