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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00016523 |
This multicenter trial tests whether inhaled nitric oxide will reduce death or the need for oxygen in preterm infants (less than 34 weeks gestational age) with severe lung disease.
Condition | Intervention | Phase |
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Respiratory Distress Syndrome Infant, Premature Sepsis Pneumonia Hypertension, Pulmonary |
Drug: inhaled nitric oxide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure |
Estimated Enrollment: | 440 |
Study Start Date: | January 2001 |
Estimated Study Completion Date: | September 2005 |
This multicenter, randomized, double-masked, controlled clinical trial evaluates the efficacy of inhaled nitric oxide (iNO) in the treatment of the preterm infant with respiratory failure secondary to respiratory distress syndrome (RDS), sepsis/pneumonia, aspiration syndrome, idiopathic pulmonary hypertension and/or suspected pulmonary hypoplasia. Infants are followed until death or discharge to home. The trial compares iNO therapy to mock gas delivery as the control and otherwise incorporates conventional management strategies (including treatment with surfactant and high frequency ventilation as adjuncts to iNO therapy). During the initial dosing, iNO is started at 5 ppm and may be increased to 10 ppm. If the infant does not respond, study gas is discontinued. For infants who respond to study gas, a gradual weaning is initiated following a well-defined protocol. The total exposure to study gas may not exceed 336 hours (14 days). Infants are monitored for signs of toxicity. Medical and neurodevelopmental outcome of surviving infants will be assessed at 18 to 22 months corrected age by masked, certified examiners.
To demonstrate that the use of iNO is associated with a clinically significant reduction (from 75% to 60%) in the primary outcome variable (incidence of death or BPD during initial hospitalization) using a power of 0.90 and an alpha of 0.05 for a two-tailed test, a sample of 440 will be required (220 infants in each arm of the study).
Ages Eligible for Study: | up to 120 Hours |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
or
Exclusion Criteria
United States, Alabama | |
University of Alabama | |
Birmingham, Alabama, United States | |
United States, California | |
Stanford University | |
Stanford, California, United States | |
University of California San Diego | |
San Diego, California, United States | |
United States, Connecticut | |
Yale University | |
New Haven, Connecticut, United States | |
United States, Florida | |
University of Miami | |
Miami, Florida, United States | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States | |
United States, Indiana | |
University of Indiana | |
Indianapolis, Indiana, United States | |
United States, Michigan | |
Wayne State University | |
Detroit, Michigan, United States | |
United States, New York | |
University of Rochester | |
Rochester, New York, United States | |
United States, Ohio | |
University of Cincinnati | |
Cincinnati, Ohio, United States | |
United States, Rhode Island | |
Brown University | |
Providence, Rhode Island, United States | |
United States, Texas | |
University of Texas Southwestern Medical Center | |
Dallas, Texas, United States | |
University of Texas | |
Houston, Texas, United States |
Principal Investigator: | Krisa VanMeurs, MD | Stanford University |
Study ID Numbers: | NICHD-1011 |
Study First Received: | May 14, 2001 |
Last Updated: | February 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00016523 |
Health Authority: | United States: Food and Drug Administration |
Inhaled nitric oxide Preterm infants RDS Sepsis/pneumonia |
Aspiration syndrome Idiopathic pulmonary hypertension Pulmonary hypoplasia |
Systemic Inflammatory Response Syndrome Idiopathic pulmonary hypertension Respiratory Distress Syndrome, Adult Respiration Disorders Vascular Diseases Inflammation Nitric Oxide Sepsis |
Respiratory Tract Diseases Respiratory Tract Infections Hypertension, Pulmonary Lung Diseases Acute respiratory distress syndrome Pneumonia Hypertension |
Respiratory System Agents Vasodilator Agents Neurotransmitter Agents Antioxidants Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents Cardiovascular Agents Infection Protective Agents |
Pharmacologic Actions Pathologic Processes Autonomic Agents Syndrome Therapeutic Uses Free Radical Scavengers Endothelium-Dependent Relaxing Factors Cardiovascular Diseases Peripheral Nervous System Agents Bronchodilator Agents |