PECARN Network
revised
9/28/15

 

Application of Transcriptional Signatures for Diagnosis of Febrile Infants Within the PECARN Network (TIG)


Study Type: Prospective, observational clinical research
Study Period: January 2009 - December 2010
Enrollment:
  • Total # of eligible and consented subjects: 2246
  • Total # of patients with a sample obtained: 1883
  • Total # of subjects with an RNA sample analyzed: 279

Consent: Yes

PURPOSE:

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.

This Public Use Dataset is based on a limited set of data for the overall study titled above. This dataset includes patients that were analyzed as part of the analysis for defining RNA transcriptional biosignatures to distinguish febrile infants 60 days of age and younger with bacterial and non-bacterial infections. The total number of samples analyzed for the TIG data set is 279. Enrollment period for the TIG data set is January 2009-December 2010.

 

Study Documents:
Study Datasets: