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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Respiratory Insufficiency, Anoxemia

Intervention / Treatment
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* Drug: Nitrogen gas
* Drug: inhaled nitric oxide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br>Nitrogen gas | Drug: Nitrogen gas<br>* Nitrogen gas will be given at 5ppm until Day 28 or extubation<br>|
| Experimental: 1<br>Inhaled Nitric Oxide | Drug: inhaled nitric oxide<br>* inhaled nitric oxide will be given at 5 ppm until day 28 or extubation<br>* Other names: INOmax®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial blood gases |  | baseline through 24 hours and extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| methemoglobin |  | baseline, hour 4 and 24 hours | 
| broncho-alveolar lavage fluid |  | baseline, 48 hours and day 5 | 
| Prone position |  | baseline then daily | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute hypoxemic respiratory failure