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Pulmonary Valve Insufficiency clinical trials

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NCT ID: NCT00005776 Terminated - Clinical trials for Respiratory Insufficiency

Inhaled Nitric Oxide Study for Respiratory Failure in Newborns

NINOS
Start date: October 1995
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT00005774 Terminated - Clinical trials for Respiratory Insufficiency

Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants

Surfactant 2
Start date: May 2000
Phase: Phase 3
Study type: Interventional

Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. This multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced mechanical ventilation usage without added complications. Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.

NCT ID: NCT00005773 Terminated - Clinical trials for Respiratory Insufficiency

Early Inhaled Nitric Oxide for Respiratory Failure in Newborns

Early iNO
Start date: August 1998
Phase: Phase 3
Study type: Interventional

This prospective, randomized controlled trial tested whether initiating iNO therapy earlier would reduce death and reduce the use of extracorporeal membrane oxygenation (ECMO) -- temporary lung bypass -- therapy compared with the standard recommendation threshold. Infants who were born at >34 weeks' gestation were enrolled when they required assisted ventilation and had an oxygenation index (OI) >15 and <25 on any 2 measurements in a 12-hour interval. Infants were randomized to receive either early iNO or to simulated initiation of iNO (control). Infants who had an increase in OI to 25 or more were given iNO as standard therapy. The neurodevelopment of the subjects were evaluated at 18-22 months corrected age.