Pediatrics
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
A multicenter randomized masked comparison trial of synthetic surfactant versus calf lung surfactant extract in the prevention of neonatal respiratory distress syndrome.
To compare the efficacy and safety of a synthetic surfactant (Exosurf Neonatal, Burroughs Wellcome Co) and a surfactant extract of calf lung lavage (Infasurf, IND #27,169, ONY, Inc) in the prevention of neonatal respiratory distress syndrome (RDS). ⋯ Significant reductions in the incidence of RDS, the severity of early respiratory disease, the incidence of pulmonary air leaks associated with RDS, and the mortality attributable to RDS suggest that Infasurf is a more effective surfactant preparation than Exosurf Neonatal in the prophylaxis of RDS. However, Infasurf prophylaxis as used in this study was also associated with a greater risk of total but not severe IVH.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Comparison of Infasurf (calf lung surfactant extract) to Survanta (Beractant) in the treatment and prevention of respiratory distress syndrome.
To compare the relative safety and efficacy of Infasurf (calf lung surfactant extract; ONY, Inc, Amherst, NY, IND #27169) versus Survanta (Beractant, Ross Laboratories, Columbus, OH) in reducing the acute severity of respiratory distress syndrome (RDS) when given at birth and to infants with established RDS. ⋯ Infants treated with Infasurf have a modest benefit in the acute phase of RDS. Infasurf seems to produce a longer duration of effect than Survanta.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Inhaled nitric oxide and hypoxic respiratory failure in infants with congenital diaphragmatic hernia. The Neonatal Inhaled Nitric Oxide Study Group (NINOS).
We designed and conducted a randomized, double-masked, controlled multicenter study to determine whether inhaled nitric oxide (INO) in term and near-term infants with congenital diaphragmatic hernia (CDH) would reduce the occurrence of death and/or the initiation of extracorporeal membrane oxygenation (ECMO). ⋯ Although the immediate short-term improvements in oxygenation seen in some treated infants may be of benefit in stabilizing responding infants for transport and initiation of ECMO, we conclude that for term and near-term infants with CDH and hypoxemic respiratory failure unresponsive to conventional therapy, inhaled NO therapy as used in this trial did not reduce the need for ECMO or death.
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Multicenter Study Clinical Trial
Does ribavirin impact on the hospital course of children with respiratory syncytial virus (RSV) infection? An analysis using the pediatric investigators collaborative network on infections in Canada (PICNIC) RSV database.
To determine the relationship between receipt of aerosolized ribavirin and the hospital course of high-risk infants and children with respiratory syncytial virus (RSV) lower respiratory infection (LRI). ⋯ These data raise further doubts about the clinical effectiveness of ribavirin in infants and children with risk factors for severe disease. Selection bias, with ribavirin used for sicker children, may have influenced outcome. Nevertheless the long durations of hospitalization, ICU, ventilation, and oxygen supplementation in nonventilated ribavirin recipients stress the need for further randomized trials to assess its efficacy.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Pediatric mortality probability estimated from pre-ICU severity of illness.
The Pediatric Risk of Mortality (PRISM) score is a measure of illness severity based on abnormalities observed in the bedside examination and laboratory assessment. PRISM scores obtained after pediatric intensive care unit (PICU) admission predict mortality probability, but no previous efforts to evaluate mortality risk before PICU admission have been reported. Our study was performed on patients admitted to PICUs at four pediatric tertiary care centers to derive a quantitative estimate of hospital mortality probability as a function of PRISM scores obtained at referring hospitals before PICU transfer. Performance of the model was tested by evaluating accuracy of mortality predictions obtained from pre-ICU PRISM scores in a separate validation set of patients. ⋯ The pre-ICU PRISM score as a measure of illness severity provides an estimate of hospital mortality probability. Further investigation is required to determine the use of pre-ICU mortality estimates in making clinical decisions.