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.

Condition	Treatment or Intervention	Phase
Respiratory Insufficiency Anoxemia	Drug: INOmax (nitric oxide for inhalation)	Phase III

Further Study Details: 

Expected Total Enrollment:  350

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.

Ages Eligible for Study:  up to  16 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

• Admitted to pediatric intensive care unit and have the diagnosis of acute repiratory 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

Robert Small      908-238-6605    Robert.Small@inotherapy.com

California
      Chrildren's Hospital of Orange County, Orange,  California,  92868,  United States; Recruiting
      Stanford University Medical Center, Stanford,  California,  94305,  United States; Recruiting
Colorado
      The Children's Hospital, Denver,  Colorado,  80218,  United States; Recruiting
Florida
      Nemours Children's Clinic, Orlando,  Florida,  32806,  United States; Recruiting
Georgia
      Children's Healthcare of Atlanta at Egleston, Atlanta,  Georgia,  30322,  United States; Recruiting
Illinois
      University of Chicago, Children's Hospital, Chicago,  Illinois,  60637,  United States; Recruiting
Louisiana
      Louisiana State University Health Sciences Center - Shreveport, Shreveport,  Louisiana,  71103,  United States; Recruiting
Maryland
      The Johns Hopkins Hospital, Baltimore,  Maryland,  21287,  United States; Recruiting
New York
      New York Presbyterian Hospital, New York,  New York,  10021,  United States; Not yet recruiting
      Children's Hospital at Montefiore, Bronx,  New York,  10467,  United States; Recruiting
Ohio
      Children's Hospital Medical Center of Akron, Akron,  Ohio,  44308,  United States; Recruiting
      Children's Hospital, Columbus,  Ohio,  43205,  United States; Recruiting
      The Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States; Not yet recruiting
Oregon
      Oregon Health and Science University, Portland,  Oregon,  97239,  United States; Recruiting
South Carolina
      The Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States; Not yet recruiting
Virginia
      University of Virginia Pediatric Critical Care, Charlottesville,  Virginia,  22908,  United States; Recruiting

Study ID Numbers:  INOT-11
Record last reviewed:  February 2005
Last Updated:  February 7, 2005
Record first received:  July 10, 2002
ClinicalTrials.gov Identifier:  NCT00041561
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08