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Inhaled Nitric Oxide Study for Respiratory Failure in Newborns. Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Inhaled Nitric Oxide Study for Respiratory Failure in Newborns. conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Inhaled Nitric Oxide Study for Respiratory Failure in Newborns. Clinical research trials and Inhaled Nitric Oxide Study for Respiratory Failure in Newborns. healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Inhaled Nitric Oxide Study for Respiratory Failure in Newborns.. Inhaled Nitric Oxide Study for Respiratory Failure in Newborns. Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Inhaled Nitric Oxide Study for Respiratory Failure in Newborns. clinical trial. Human subjects often receive the most effective healthcare possible for their Inhaled Nitric Oxide Study for Respiratory Failure in Newborns. condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Inhaled Nitric Oxide Study for Respiratory Failure in Newborns.  Inhaled Nitric Oxide Study for Respiratory Failure in Newborns.
Inhaled Nitric Oxide Study for Respiratory Failure in Newborns.
For Condition: Respiratory Distress Syndrome,Meconium Aspiration,Respiratory Insufficiency,Infant, Newborn, Diseases,Persistent Fetal Circulation Syndrome,Pneumonia, Aspiration,Hypertension, Pulmonary
Status: Terminated
Sponsor(s): National Institute of Child Health and Human Development (NICHD) , Medical Research Council of Canada
Synopsis: Respiratory failure in term newborns is associated with increased rates of death and long-term neurodevelopmental problems. This large international multicenter trial randomized newborns who had failed to respond to intensive care, including high levels of ventilator support, to receive either inhaled nitric oxide (iNO) or 100 percent oxygen to test whether iNO would decrease their risk of dying or requiring temporary lung bypass. Infants were followed during their initial hospitalization; their outcome was assessed at 18 to 24 mos of age.
Details: Respiratory failure in term newborns is associated with significant morbidity and mortality, despite maximal conventional therapy. Neonates with pulmonary hypertension have been treated with iNO, a selective pulmonary vasodilator. This multicenter, double-masked placebo-controlled randomized trial tested whether iNO would reduce the risk of death and/or the initiation of extracorporeal membrane oxygenation (ECMO) in a prospectively defined cohort of term or near-term neonates with hypoxic respiratory failure unresponsive to conventional therapy. The sample size was based on a reduction of the primary event (death or ECMO) from 50 percent to 30 percent; 90 percent power; and a two-tailed Type I error of 0.05. Infants were evaluated at baseline for pulmonary, cardiac, bleeding status, and therapies received. Those who were greater than 34 wks gestation and 14 days old or less and required assisted ventilation with an OI (mean airway pressure x FiO2 divided by the PaO2 x 100) greater than 25 were eligible. They were randomly assigned to receive iNO at 20 ppm or 100 percent oxygen as a control. Infants whose PaO2 increased by less than 20 mm Hg after 30 minutes were studied at 80ppm iNO or control gas.; MetHg and NO2 concentrations were monitored regularly. Management, including surfactant administration, included prospectively defined criteria for study gas response, escalation, reinitiation, and weaning. The maximum total time on study gas was 336 hrs (after 240 hrs, the INO concentration was required to be no more than 5 ppm). Patients were followed to death, discharge, or 120 days and evaluated at 18-24 mos by a masked certified examiner.
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 wks gestational age - One or more of the following diagnoses: primary pulmonary hypertension of the newborn, respiratory distress syndrome, perinatal aspiration syndrome, pneumonia/sepsis, suspected pulmonary hypoplasia - Oxygenation Index (OI) greater than 15 and less than 25 on 2 arterial blood gases at least 15 min apart - Indwelling arterial line - Echocardiography before randomization - Parental consent Exclusion Criteria: - Congenital diaphragmatic hernia - Known congenital heart disease - Decision not to provide full therapy
Total Enrollment: 235
Location and Contact Information:
Overall Study Official:
RichardEhrenkranz, Principal Investigator, Yale University
Additional Information:
Study ID Numbers: NICHD-1002; U10 HD21415,U10 HD27851,U10 HD27880,M01 RR00750,U10 HD34167,U10 HD27881,M01 RR06022,M01 RR00070,U10 HD34216,U01 HD19897,M01 RR00997,U10 HD21373,M01 RR01032,M01 RR08084,U10 HD27904,U10 HD21397,U10 HD21385,U10 HD27871,U10 HD27853
Study Start Date: October 1995
Record last reviewed: April 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005776
Other Respiratory Distress Syndrome Studies:
1. Phase IV Study of Chronic Infusional Epoprostenol for Severe Primary Pulmonary Hypertension
2. Pulmonary Hypertension--Mechanisms and Family Registry
3. Early Inhaled Nitric Oxide for Respiratory Failure in Newborns
4. Inhaled Nitric Oxide Study for Respiratory Failure in Newborns.
5. The Effect of Tracleerâ„¢ on Male Fertility
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Inhaled Nitric Oxide Study for Respiratory Failure in Newborns.
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