The purpose of this funding announcement is to invite applications to form a research network to conduct multisite clinical studies in pediatric critical care medicine. The Network will be comprised of a Data Coordinating Center (DCC) and at least seven Clinical Sites. The Network is designed to investigate the efficacy of treatment and management strategies to care for critically ill and injured children, as well as to better understand the pathophysiological bases of critical illness and injury in childhood.
The CPCCRN was established in 2004 to conduct multisite research among critically ill and injured children. Given the relatively small and vastly heterogeneous pool of critically ill pediatric patients, multisite research is necessary to advance the field. Despite significant advances in pediatric critical care research, there remains a need for evidence-based data to inform care of critically ill and injured children. Given the urgent and complex milieu of pediatric critical care, treatment is often based on limited knowledge of new modalities not subjected to rigorous study. As a result, pediatric critical care therapies may be incorporated into practice based on limited experience with efficacy and/or safety virtually unevaluated scientifically. Further, the longer-term consequences of critical illness and/or injury in childhood are not well studied, either for individual children and their families or for the larger communities into which they are re-integrated. Mortality has become a relatively rare outcome in U.S. pediatric critical care units, and the relationship of critical care treatments and strategies to morbidity, development, and the re-integration barriers for children, their families, and the larger communities of school and peer groups remain understudied and poorly understood.
A well-supported Network with a high-functioning DCC and established Clinical Sites infrastructure and expertise is the most efficient and effective method to conduct such research. The portfolio of studies completed by previous CPCCRN Networks included a wide array of critical care issues including, but not limited to sepsis, acute respiratory distress, and multiple organ dysfunction syndrome. The Network also implemented a biorepository protocol as well as prepared and posted several robust public use datasets in the NICHD Data and Specimen Hub (DASH).
This collaborative research network will accelerate pediatric critical care research, leading to evaluation of promising new approaches to life support and critical decision-making in complex childhood illnesses and injuries. Multisite research projects including, but not limited to clinical trials, have the potential to reduce the number of patients needed at any individual clinical site and allow subject accrual and meaningful translational and descriptive research to be more rapidly completed. Further, common protocols have the potential to reduce the effect of variables that contribute to patient outcomes, allowing for valid comparisons between treatments. The network approach will increase the number of comparative trials and meaningful translational and descriptive studies that are conducted by providing a framework for rapid initiation of important studies as their public health significance for children becomes apparent, through the efficient use of pooled scientific and clinical expertise and data management resources.
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