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

• Status: Terminated
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mallinckrodt
• Treatments: Nitric Oxide

Criteria

Inclusion criteria:

• Admitted to pediatric intensive care unit and have the diagnosis of acute respiratory failure

• 44 weeks post conceptional age to 16 years of age

• Oxygenation Index (OI) >=12 cm H2O/mmHg (as determined by two separate measurement taken 30 minutes to 4 hours apart)

• Recent chest x-ray (within 24 hours) showing at least unilateral infiltrations

• Mechanically ventilated <= 7 days

Exclusion criteria:

• Immunocompromised

• Received a bone marrow transplant

• Active oncological condition

• Persistent right to left intracardiac shunt

• Cardiovascular surgery within the last 14 days

• Status asthmaticus

• Decision by primary care physician not to provide full support

• Received treatment with nitric oxide for inhalation or other investigational medications within 24 hours prior to study initiation, participating in surfactant trials

• Chronically ventilated

• Pregnant