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

Sponsor:	INO Therapeutics
Information provided by:	INO Therapeutics
ClinicalTrials.gov Identifier:	NCT00041561

Purpose

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	Intervention	Phase
Respiratory Insufficiency Anoxemia	Drug: Nitrogen gas Drug: inhaled nitric oxide	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	The Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) In Pediatrics

Resource links provided by NLM:

MedlinePlus related topics: Gas

Drug Information available for: Nitric oxide

U.S. FDA Resources

Further study details as provided by INO Therapeutics:

Primary Outcome Measures:

arterial blood gases [ Time Frame: baseline through 24 hours and extubation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

methemoglobin [ Time Frame: baseline, hour 4 and 24 hours ] [ Designated as safety issue: Yes ]
broncho-alveolar lavage fluid [ Time Frame: baseline, 48 hours and day 5 ] [ Designated as safety issue: No ]
Prone position [ Time Frame: baseline then daily ] [ Designated as safety issue: No ]

Enrollment:	55
Study Start Date:	January 2002
Study Completion Date:	December 2004
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 2 Nitrogen gas	Drug: Nitrogen gas Nitrogen gas will be given at 5ppm until Day 28 or extubation
Experimental: 1 Inhaled Nitric Oxide	Drug: inhaled nitric oxide inhaled nitric oxide will be given at 5 ppm until day 28 or extubation Other Name: INOmax®

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

Ages Eligible for Study:	up to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041561

Locations

United States, California
Chrildren's Hospital of Orange County
Orange, California, United States, 92868
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Colorado
The Children's Hospital
Denver, Colorado, United States, 80218
United States, Florida
Nemours Children's Clinic
Orlando, Florida, United States, 32806
United States, Georgia
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago, Children's Hospital
Chicago, Illinois, United States, 60637
United States, Louisiana
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States, 71103
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, New York
Children's Hospital at Montefiore
Bronx, New York, United States, 10467
New York Presbyterian Hospital
New York, New York, United States, 10021
United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Children's Hospital
Columbus, Ohio, United States, 43205
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, South Carolina
The Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Virginia
University of Virginia Pediatric Critical Care
Charlottesville, Virginia, United States, 22908

Sponsors and Collaborators

INO Therapeutics

Investigators

Study Director:

James Baldassarre, MD

INO Therapeutics

More Information

No publications provided

Responsible Party:	James Baldassarre, INO Therapeutics
ClinicalTrials.gov Identifier:	NCT00041561 History of Changes
Other Study ID Numbers:	INOT-11
Study First Received:	July 10, 2002
Last Updated:	June 14, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by INO Therapeutics:

Acute hypoxemic respiratory failure

Additional relevant MeSH terms:

Anoxia
Respiratory Insufficiency
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on February 12, 2012