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

Phase 3TerminatedNCT00041561

Mallinckrodt55 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Respiratory Insufficiency Anoxemia

Interventions

Nitrogen gasDRUG

Nitrogen gas will be given at 5ppm until Day 28 or extubation

inhaled nitric oxideDRUG

inhaled nitric oxide will be given at 5 ppm until day 28 or extubation

Eligibility

Sex: ALLMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (16)

Chrildren's Hospital of Orange County

Orange, California, United States

Stanford University Medical Center

Stanford, California, United States

Outcomes

Primary Outcomes

arterial blood gases

Time frame: baseline through 24 hours and extubation

Secondary Outcomes

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

Data from ClinicalTrials.gov

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