Clinical trial NCT00041561: Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) in Pediatrics
Official title: The Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) In Pediatrics
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Respiratory Insufficiency
Anoxemia
Keywords: Acute hypoxemic respiratory failure
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2002-07-11
Enrollment: 55
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: arterial blood gases
timeFrame: baseline through 24 hours and extubation
Secondary outcomes:
measure: methemoglobin
timeFrame: baseline, hour 4 and 24 hours
measure: broncho-alveolar lavage fluid
timeFrame: baseline, 48 hours and day 5
measure: Prone position
timeFrame: baseline then daily
Other outcomes:
Locations:
city: Orange
country: United States
facility: Chrildren's Hospital of Orange County
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Denver
country: United States
facility: The Children's Hospital
state: Colorado
city: Orlando
country: United States
facility: Nemours Children's Clinic
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Egleston
state: Georgia
city: Chicago
country: United States
facility: University of Chicago, Children's Hospital
state: Illinois
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center - Shreveport
state: Louisiana
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Bronx
country: United States
facility: Children's Hospital at Montefiore
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Akron
country: United States
facility: Children's Hospital Medical Center of Akron
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Children's Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Charleston
country: United States
facility: The Medical University of South Carolina
state: South Carolina
city: Charlottesville
country: United States
facility: University of Virginia Pediatric Critical Care
state: Virginia
Study officials:
affiliation: Mallinckrodt
name: James Baldassarre, MD
role: STUDY_DIRECTOR
References: