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

Stopped early · Phase 3

Conditions studied: Respiratory Insufficiency, Anoxemia

In brief

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.

Key facts

Study ID

NCT00041561

Run by

Mallinckrodt

People needed

55

Starts

2002-01-01

Expected to finish

2004-12-01

Last updated by the study team

2016-07-26

Who can join

Age: any, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Chrildren's Hospital of Orange County — Orange, California, United States
• Stanford University Medical Center — Stanford, California, United States
• The Children's Hospital — Denver, Colorado, United States
• Nemours Children's Clinic — Orlando, Florida, United States
• Children's Healthcare of Atlanta at Egleston — Atlanta, Georgia, 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
• New York Presbyterian Hospital — New York, New York, United States
• Children's Hospital at Montefiore — The Bronx, New York, United States
• Children's Hospital Medical Center of Akron — Akron, Ohio, United States
• The Cleveland Clinic Foundation — Cleveland, 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

Full record on ClinicalTrials.gov

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