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

Mallinckrodt

Status and phase

Terminated

Phase 3

Conditions

Anoxemia

Respiratory Insufficiency

Treatments

Drug: Nitrogen gas

Drug: inhaled nitric oxide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00041561

INOT-11

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 patients

Sex

All

Ages

Under 16 years old

Volunteers

No Healthy Volunteers

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