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Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Canadian Institutes of Health Research (CIHR) INO Therapeutics |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00005773 |
Inhaled nitric oxide reduces the risk of temporary lung bypass in term and near-term infants with severe respiratory failure. Term and near-term infants with mild to moderate respiratory failure on a ventilator are randomized to inhaled nitric oxide to 100 percent oxygen to determine if administration of inhaled nitric oxide earlier in their course or to infants with less severe respiratory failure decreases the incidence of death or ECMO. The neurodevelopment of infants will be evaluated at 18 to 24 months of age.
Condition | Intervention | Phase |
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Hypertension, Pulmonary Respiratory Insufficiency Infant, Newborn, Diseases Meconium Aspiration Persistent Fetal Circulation Syndrome Pneumonia, Aspiration Respiratory Distress Syndrome |
Drug: Inhaled Nitric Oxide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Early Inhaled Nitric Oxide Therapy in Term and Near Term Infants With Respiratory Failure |
Estimated Enrollment: | 400 |
Study Start Date: | August 1998 |
Estimated Study Completion Date: | September 2001 |
Respiratory failure occurs in near term and term infants as a complication of perinatal aspiration syndromes, pneumonia, sepsis, respiratory distress syndrome and primary pulmonary hypertension. Recently the collaborative trial of the NICHD Neonatal Research Network and the Canadian Inhaled Nitric Oxide Study Group (the NINOS trial) demonstrated that inhaled nitric oxide decreases the need for ECMO/death from 64 percent in the control group to 46 percent in term/near term infants with respiratory failure. The purpose of this study is to determine if administration of inhaled nitric oxide earlier in the course of respiratory failure and to infants with less severe respiratory failure, decreases the incidence of ECMO or death, as suggested by the sub-group analysis of the original NINOS trial. Infants are enrolled at gestational age greater than 34 weeks (near term and term). The study is prospective, randomized and double masked. The study will compare the outcome of infants received INO at OI greater than 15 and less than 25, with a control group that does not receive early INO. INO will be delivered at 20 ppm during the initial dose-response evaluation. Infants in either group who show subsequent deterioration with OI greater than 25 on two consecutive ABGs at least one hour apart or a rapid deterioration with OI greater than 30 on two consecutive ABGs 15 minutes apart receive open label INO therapy as part of standard medical management. Specific guidelines are followed for the use of high frequency ventilation and surfactant during study gas administration to prevent them from confounding the results of the study.
Secondary hypotheses include the following: early INO will reduce the probability of OI exceeding 25 on two consecutive blood gases drawn at least one hour apart or an OI greater than 30 on two consecutive ABGs 15 minutes apart; Early INO therapy will reduce the probability of OI exceeding 40 on 2 consecutive arterial blood gases done at least 30 minutes apart; there will be no difference in neurodevelopmental or hearing impairments evaluated at 18-24 months of corrected age between INO treated and control groups.
A sample size of 400 infants (200 each for placebo and INO arms) will be needed to detect an anticipated decrease in probability of death/initiation of ECMO from 35 percent in the control group to 20 percent in the INO group at 95 percent confidence level and with 90 percent power, using a two-tailed hypothesis.
Ages Eligible for Study: | up to 14 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama | |
Birmingham, Alabama, United States, 35294 | |
United States, Arizona | |
St. Joseph's Hospital | |
Phoenix, Arizona, United States, 85013 | |
United States, California | |
Stanford University | |
Palo Alto, California, United States, 94304 | |
San Diego Children's Hospital | |
San Diego, California, United States, 92130 | |
United States, Connecticut | |
Yale University | |
New Haven, Connecticut, United States, 06520 | |
United States, Florida | |
University of Miami | |
Miami, Florida, United States, 33101 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30335 | |
United States, Indiana | |
Indiana University | |
Indianapolis, Indiana, United States, 46202-4716 | |
United States, Michigan | |
Wayne State University | |
Detroit, Michigan, United States, 48201 | |
United States, New Mexico | |
University of New Mexico | |
Albuquerque, New Mexico, United States, 87131 | |
United States, Ohio | |
Case Western Reserve University | |
Cleveland, Ohio, United States, 44106 | |
University of Cincinnati | |
Cincinnati, Ohio, United States, 45267-0541 | |
United States, Rhode Island | |
Women and Infants | |
Providence, Rhode Island, United States, 02903 | |
United States, Tennessee | |
University of Tennessee | |
Memphis, Tennessee, United States, 38163 | |
United States, Texas | |
University of Texas | |
Dallas, Texas, United States, 75235 | |
University of Texas | |
Houston, Texas, United States | |
Texas Children's Hospital | |
Houston, Texas, United States, 77030 | |
United States, Washington | |
University of Washington School of Medicine | |
Seattle, Washington, United States, 98195 |
Principal Investigator: | Ganesh Konduri | University of Wisconsin, Madison |
Study ID Numbers: | NICHD-1005, U10 HD21397, U10 HD27853, U10 HD27871, U10 HD21364, U10 HD21415, U10 HD27856, U10 HD27904, U10 HD27881, U10 HD21385, U10 HD27880, U10 HD21373, U10 HD34216 |
Study First Received: | June 1, 2000 |
Last Updated: | February 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00005773 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Administration, inhalation Double-blind method Hypoxic respiratory failure Infant, newborn Infant, premature Meconium aspiration/complications Methemoglobinemia/chemically induced |
Nitric oxide/adverse effects Oxygen/blood Oxygen inhalation therapy Persistent fetal circulation syndrome/complications Respiratory distress syndrome/complications Respiratory insufficiency/etiology Severe respiratory failure |
Neurotransmitter Agents Vasodilator Agents Pregnancy Complications Antioxidants Respiratory Distress Syndrome, Adult Fetal Diseases Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Infant, Newborn, Diseases Meconium Aspiration Syndrome Respiration Disorders Vascular Diseases |
Acute Respiratory Distress Syndrome Anti-Asthmatic Agents Pneumonia, Aspiration Cardiovascular Agents Nitric Oxide Hypertension, Pulmonary Lung Diseases Persistent Fetal Circulation Syndrome Peripheral Nervous System Agents Bronchodilator Agents Pneumonia Hypertension |
Respiratory System Agents Vasodilator Agents Neurotransmitter Agents Antioxidants Pregnancy Complications Molecular Mechanisms of Pharmacological Action Respiratory Distress Syndrome, Adult Physiological Effects of Drugs Fetal Diseases Respiratory Insufficiency Pathologic Processes Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses Syndrome |
Free Radical Scavengers Endothelium-Dependent Relaxing Factors Infant, Newborn, Diseases Cardiovascular Diseases Meconium Aspiration Syndrome Disease Respiration Disorders Vascular Diseases Anti-Asthmatic Agents Pneumonia, Aspiration Cardiovascular Agents Protective Agents Pharmacologic Actions Nitric Oxide Hypertension, Pulmonary |