In May 2005, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) established the Collaborative Pediatric Critical Care Research Network (CPCCRN) to support multi-institutional randomized controlled trials (RCTs) and observational studies in critically ill children, and the network was competitively renewed in 2009. The CPCCRN currently consists of seven core Clinical Centers, and the Data Coordinating Center (DCC). Since it was established nine years ago, the CPCCRN and its investigators have considered 61 research concepts, created a network registry, implemented 23 studies (including the NHLBI-funded Therapeutic Hypothermia after Pediatric Cardiac Arrest (THAPCA) Trials), published 39 peer-reviewed publications, and produced seven public use datasets that are freely available to enable research by additional investigators. Going forward, in addition to the network registry and the THAPCA Trials, CPCCRN has five on-going studies that are anticipated to continue through at least early 2016. These include observational studies of the complications of extracorporeal membrane oxygenation (ECMO) and hemodynamic analyses of cardiopulmonary resuscitation in the intensive care unit, a pharmacometric evaluation of antibiotics during ECMO, and two R01-funded sepsis studies. The University of Utah has been the DCC since network inception, and proposes to continue in this role during the next five years. The DCC faculty bring recognized clinical, biostatistical and informatics expertise to the CPCCRN. This proposal has three specific aims.
Specific Aim 1. Provide clinical and biostatistical leadership and expertise, assistance in study and protocol design, study implementation and management, tracking and delivery methods for study drugs and biological specimens, study training, data collection and management, site monitoring, study reporting, interim and final study analyses, publication of study results, and production of public use research datasets.
Specific Aim 2. Provide logistical support for CPCCRN (including financial management of protocol funds), using advanced communication and informatics tools for development and tracking of critical documents, including study protocols, FAQ documents, Manuals of Operation, training materials, IRB and other regulatory documents, study publications, DSMB reports, and provision of accounting information to NICHD.
Specific Aim 3. Improve efficiency of studies by continuing the voluntary CPCCRN central IRB and refining methods for direct data collection from CPCCRN electronic health records.
The Collaborative Pediatric Critical Care Research Network (CPCCRN) carries out clinical trials and studies to improve the science of pediatric intensive care, and to reduce the mortality and improve the long term outcome for infants and children who suffer from critical illness or injury.
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