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

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

MedlinePlus related topics:

Children's Health

ChemIDplus related topics:

Nitric oxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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
2: Placebo Comparator Nitrogen gas	Drug: Nitrogen gas Nitrogen gas will be given at 5ppm until Day 28 or extubation
1: Experimental Inhaled Nitric Oxide	Drug: inhaled nitric oxide inhaled nitric oxide will be given at 5 ppm until day 28 or extubation

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
	New York Presbyterian Hospital
	New York, New York, United States, 10021
	Children's Hospital at Montefiore
	Bronx, New York, United States, 10467

United States, Ohio
	Children's Hospital Medical Center of Akron
	Akron, Ohio, United States, 44308
	Children's Hospital
	Columbus, Ohio, United States, 43205
	The Cleveland Clinic Foundation
	Cleveland, Ohio, United States, 44195

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

Responsible Party:	INO Therapeutics ( James Baldassarre )
Study ID Numbers:	INOT-11
First Received:	July 10, 2002
Last Updated:	February 26, 2008
ClinicalTrials.gov Identifier:	NCT00041561
Health Authority:	United States: Food and Drug Administration

Keywords provided by INO Therapeutics:

Acute hypoxemic respiratory failure

Study placed in the following topic categories:

Nitric Oxide

Respiratory Insufficiency

Respiratory Tract Diseases

Respiration Disorders

Anoxia

Additional relevant MeSH terms:

Respiratory System Agents

Vasodilator Agents

Neurotransmitter Agents

Antioxidants

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Anti-Asthmatic Agents

Cardiovascular Agents

Protective Agents

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Free Radical Scavengers

Endothelium-Dependent Relaxing Factors

Peripheral Nervous System Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on September 05, 2008

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