Application of Transcriptional Signatures for Diagnosis of Febrile Infants Within the Pediatric Emergency Care Applied Research Network (PECARN)
Study Type: Prospective, observational clinical research
Study Period: December 2008 - May 20136
- Total # of eligible and consented subjects: 6014
- Total # of patients with a sample obtained: 4778
The ultimate goal of this project was to incorporate a RNA-based diagnostic technology (called transcriptional signatures) to distinguish between bacterial and non-bacterial infections in otherwise well-appearing febrile infants who presented to the Emergency Department. The project aimed to create a PECARN wide infrastructure for conducting translational genomic research and demonstrate feasibility of screening, consenting, collecting, and processing of small volumes of blood samples to abstract high quality RNA from febrile infants. After initially defining bacterial and non-bacterial biosignatures, a limited validation of these diagnostic biosignatures was conducted on an independent group of febrile infants. Patient enrollment began in December 2007 and continued through May 2013 (this period includes the entire study population enrolled under the TIG [including feasibility portion prior to 2009] and NIH grants). This project was co-funded by NICHD.
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