Pediatrics
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Randomized Controlled Trial Multicenter Study Clinical Trial
A randomized trial of early versus standard inhaled nitric oxide therapy in term and near-term newborn infants with hypoxic respiratory failure.
Inhaled nitric oxide (iNO) reduces the use of extracorporeal membrane oxygenation (ECMO)/incidence of death in term and near-term neonates with severe hypoxic respiratory failure. We conducted a randomized, double masked, multicenter trial to determine whether administration of iNO earlier in respiratory failure results in additional reduction in the incidence of these outcomes. ⋯ iNO improves oxygenation but does not reduce the incidence of ECMO/mortality when initiated at an OI of 15 to 25 compared with initiation at >25 in term and near-term neonates with respiratory failure.
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Multicenter Study Clinical Trial Controlled Clinical Trial
Safety, pharmacokinetics, and pharmacodynamics of drotrecogin alfa (activated) in children with severe sepsis.
In a phase 3 trial, recombinant human activated protein C (drotrecogin alfa [activated]) significantly reduced mortality in adult patients with severe sepsis. We have now performed a preliminary analysis of the safety, pharmacokinetics, and pharmacodynamics of drotrecogin alfa (activated) in pediatric patients with severe sepsis. ⋯ Pediatric patients with severe sepsis manifest sepsis-induced coagulopathy including protein C deficiency comparable to that seen in adults with severe sepsis. The pharmacokinetics, pharmacodynamic effects, and safety profile of drotrecogin alfa (activated) in pediatric patients are similar to those previously published for adult patients. A large, phase 3, randomized, placebo-controlled study is ongoing to confirm these results and formally assess the safety and efficacy of drotrecogin alfa (activated) in children.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
A randomized, controlled trial comparing two different continuous positive airway pressure systems for the successful extubation of extremely low birth weight infants.
To determine whether the use of the Infant Flow continuous positive airway pressure (IF CPAP) system reduces the rate of extubation failure among extremely low birth weight (ELBW) infants (infants with birth weight <1000 g) when compared with conventional CPAP delivered with a conventional ventilator and nasal prongs. ⋯ Extubation failure is a common problem, occurring in nearly 40% of ELBW infants who require mechanical ventilation. IF CPAP was as effective but no more effective than conventional CPAP in preventing extubation failure among ELBW infants. New strategies are needed to identify predictors of extubation success and to treat apnea/bradycardia, the most common cause of extubation failure, thereby reducing the likelihood of prolonged intubation in this high-risk cohort of premature infants.
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Multicenter Study Comparative Study
Cognitive and academic consequences of bronchopulmonary dysplasia and very low birth weight: 8-year-old outcomes.
To examine the effects of bronchopulmonary dysplasia (BPD) and very low birth weight (VLBW) on the cognitive and academic achievement of a large sample of 8-year-old children. ⋯ BPD and duration on oxygen have long-term adverse effects on cognitive and academic achievement above and be beyond the effects of VLBW. The problems that have been identified at 8 years of age highlight the need for continued monitoring of the learning, behavior, and development of BPD children to intervene with children who are at risk for school problems.
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Multicenter Study
Effectiveness of school-based telehealth care in urban and rural elementary schools.
This study evaluated the quality and cost effectiveness of health care provided in urban and rural elementary school-based telehealth centers, using plain old telephone system (POTS) technology. ⋯ Telehealth technology was effective in delivering pediatric acute care to children in these schools. Pediatric providers, nurses, parents, and children reported primary care school-based telehealth as an acceptable alternative to traditional health care delivery systems. The POTS-based technology helps to make this telehealth service a cost-effective alternative for improving access to primary and psychiatric health care for underserved children.