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Early Inhaled Nitric Oxide for Respiratory Failure in Newborns Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Early Inhaled Nitric Oxide for Respiratory Failure in Newborns conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Early Inhaled Nitric Oxide for Respiratory Failure in Newborns Clinical research trials and Early Inhaled Nitric Oxide for Respiratory Failure in Newborns medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Early Inhaled Nitric Oxide for Respiratory Failure in Newborns. Early Inhaled Nitric Oxide for Respiratory Failure in Newborns Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Early Inhaled Nitric Oxide for Respiratory Failure in Newborns clinical trial. Participants frequently obtain the most expert healthcare available for their Early Inhaled Nitric Oxide for Respiratory Failure in Newborns condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Early Inhaled Nitric Oxide for Respiratory Failure in Newborns  Early Inhaled Nitric Oxide for Respiratory Failure in Newborns
Early Inhaled Nitric Oxide for Respiratory Failure in Newborns
For Condition: Persistent Fetal Circulation Syndrome,Meconium Aspiration,Respiratory Insufficiency,Pneumonia, Aspiration,Infant, Newborn, Diseases,Hypertension, Pulmonary,Respiratory Distress Syndrome
Status: Completed
Sponsor(s): National Institute of Child Health and Human Development (NICHD) , Canadian Institutes of Health Research,INO Therapeutics
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: /14 Days
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Greater than 34 weeks gestational age - Require assisted ventilation for hypoxic respiratory failure - One of the following diagnoses: primary persistent pulmonary hypertension (PPHN), respiratory distress syndrome, perinatal aspiration syndrome, pneumonia/sepsis, suspected pulmonary hypoplasia - An oxygen index greater than 15 and less than 25 on 2 arterial blood gases at least 15 minutes apart on Fi02 greater than 80 percent - Indwelling arterial line - Parental consent Exclusion Criteria: - Known structural congenital heart disease, except patent ductus arteriosus and atrial level shunts - Congenital diaphragmatic hernia - Use of high frequency jet ventilation at the time of randomization - Prior exposure to inhaled nitric oxide therapy
Total Enrollment: 400
Location and Contact Information:
Overall Study Official:
GaneshKonduri, Principal Investigator, University of Wisconsin
Stanford University
Palo Alto, California, 94304
United States
University of Tennessee
Memphis, Tennessee, 38163
United States
Yale University
New Haven, Connecticut, 06520
United States
Women and Infants
Providence, Rhode Island, 02903
United States
St. Joseph's Hospital
Phoenix, Arizona, 85013
United States
University of Washington School of Medicine
Seattle, Washington, 98195
United States
University of Texas
Dallas, Texas, 75235
United States
Wayne State University
Detroit, Michigan, 48201
United States
Texas Children's Hospital
Houston, Texas, 77030
United States
University of Alabama
Birmingham, Alabama, 35294
United States
Case Western Reserve University
Cleveland, Ohio, 44106
United States
Indiana University
Indianapolis, Indiana, 46202-4716
United States
University of New Mexico
Albuquerque, New Mexico, 87131
United States
University of Miami
Miami, Florida, 33101
United States
Emory University
Atlanta, Georgia, 30335
United States
University of Texas
Houston, Texas,
United States
University of Cincinnati
Cincinnati, Ohio, 45267-0541
United States
San Diego Children's Hospital
San Diego, California, 92130
United States
Additional Information:
Study ID Numbers: NICHD-1005; U10 HD27871,U10 HD27856,U10 HD21397,U10 HD27853,U10 HD21385,U10 HD27880,U10 HD34216,U10 HD27881,U10 HD21364,U10 HD27904,U10 HD21373,U10 HD21415
Study Start Date: August 1998
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005773
Other Pneumonia, Aspiration Studies:
1. Inhaled Nitric Oxide Study for Respiratory Failure in Newborns.
2. Early Inhaled Nitric Oxide for Respiratory Failure in Newborns
3. Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
Related Studies:
Other Pneumonia, Aspiration Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Early Inhaled Nitric Oxide for Respiratory Failure in Newborns
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