Pediatr Crit Care Me
-
Pediatr Crit Care Me · May 2013
The role of the Data and Safety Monitoring Board in a clinical trial: the CRISIS study.
Randomized clinical trials are commonly overseen by a Data and Safety Monitoring Board comprised of experts in medicine, ethics, and biostatistics. Data and Safety Monitoring Board responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. Data and Safety Monitoring Board decisions can affect study design and conduct, as well as reported findings. Researchers must incorporate Data and Safety Monitoring Board oversight into the design, monitoring, and reporting of randomized trials. ⋯ The design and operating procedures of a multicenter randomized trial must consider a pivotal Data and Safety Monitoring Board role. Maximum study design flexibility must be allowed, and investigators must be prepared for protocol modifications due to interim findings. The Data and Safety Monitoring Board must have sufficient clinical and statistical expertise to assess potential importance of interim treatment differences in the setting of multiple looks at accumulating data with numerous outcomes and subgroups.
-
Pediatr Crit Care Me · May 2013
Comparative StudyComparison of nasal continuous positive airway pressure delivered by seven ventilators using simulated neonatal breathing.
Nasal continuous positive airway pressure (NCPAP) is an established treatment for respiratory distress in neonates. Most modern ventilators are able to provide NCPAP. There have been no large studies examining the properties of NCPAP delivered by ventilators. The aim of this study was to compare pressure stability and imposed work of breathing (iWOB) for NCPAP delivered by ventilators using simulated neonatal breathing. ⋯ Some of the tested ventilators unexpectedly provided a minor degree of pressure support. In terms of pressure stability, we have not found any advantages of ventilators as a group compared with Bubble CPAP, Neopuff, and variable flow generators that were tested in our previous study. The variation between individual systems is great within both categories. The clinical importance of these findings needs further investigation.
-
Pediatr Crit Care Me · May 2013
Comparative StudyVolatile anesthetic rescue therapy in children with acute asthma: innovative but costly or just costly?.
To describe volatile anesthesia (VA) use for pediatric asthma, including complications and outcomes. ⋯ Mortality does not differ between centers that use VA or not. Patients treated at centers with high VA use had significantly increased hospital charges and increased LOS.
-
Pediatr Crit Care Me · May 2013
Comparative Study Clinical TrialAminoterminal pro-B-type natriuretic peptide: heart or lung disease in the neonate?.
B-type natriuretic peptides have been shown to enable differentiation between heart and lung diseases in adults and children. In neonates, the role of natriuretic peptides for diagnosis of congenital heart defect (CHD) is not yet ascertained. The purpose of this single-center prospective study was to investigate aminoterminal B-type natriuretic peptide concentrations and their time courses during the first 5 days of life in neonates with CHD compared with neonates with respiratory distress. ⋯ On the first day of life, aminoterminal B-type natriuretic peptide cannot differentiate between CHD and respiratory distress without CHD in the neonate. From the second day onwards, aminoterminal B-type natriuretic peptide in neonates with CHD shows higher values and a different time course and enables differentiation between CHD and respiratory distress due to other than cardiac reasons.
-
Pediatr Crit Care Me · May 2013
Pediatric Risk, Injury, Failure, Loss, End-Stage renal disease score identifies acute kidney injury and predicts mortality in critically ill children: a prospective study.
To determine whether Pediatric Risk, Injury, Failure, Loss, End-Stage renal disease (pRIFLE) criteria serve to characterize the pattern of acute kidney injury in critically ill pediatric patients. To identify if pRIFLE score will predict morbidity and mortality in our patient's cohort. ⋯ In this cohort of critically ill pediatric patients, acute kidney injury identified by pRIFLE and fluid overload greater than or equal to 10% predicted increased morbidity and mortality. Implementation of pRIFLE scoring and close monitoring of fluid overload upon admission may help develop early interventions to prevent and treat acute kidney injury in critically ill children.