2015 Best Pharmaceuticals for Children Act Update July 2, 2015Dear Colleagues:
We would like to thank you for your continued interest and past input into the Best Pharmaceuticals for Children Act (BPCA) program at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH). As stakeholders in this important program, we would like to keep you abreast ...
PTN featured in the Wall Street Journal June 9, 2015The Pediatric Trials made an appearance in the pages of the Wall Street Journal on June 8. Check out the story online: http://www.wsj.com/articles/how-much-of-a-drug-is-safe-for-preemies-1433784687.
PTN meropenem study published in the Federal Register May 28, 2015The PTN marks another milestone as the Food and Drug Administration (FDA) has published a summary report of its pediatric study of meropenem in the Federal Register.
Meropenem is a broad-spectrum anti-microbial drug often used to treat intra-abdominal infections in infants. The purpose of the PTN study, which began in the summer of 2008, was to ...
Mercy TAPE moves closer to market May 20, 2015The FDA has approved the 510(k) application for the Mercy TAPE—an anthropometric-based device developed by Dr. Susan Abdel-Rahman at Children’s Mercy Hospital in Kansas City that predicts weight in children 2 months through 16 years of age. The results from the PTN study validating this device appeared in the Annals of Emergency Medicine in 2013.
PTN hosts an investigator gathering at PAS 2015 May 14, 2015The PTN hosted an informational, informal gathering during the Pediatric Academic Society meeting in San Diego in late April, giving investigators and study personnel a chance to meet face to face. Thanks to all who participated!
PTN findings presented at PAS 2015 April 28, 2015Check out the results from recent PTN studies presented at this year’s annual meeting of the Pediatric Academic Societies.
Meropenem label changed to reflect PTN findings March 24, 2015The FDA recently changed the label for the drug meropenem to reflect findings from a study conducted by PTN investigators. Results from the study were published in the Pediatric Infectious Disease Journal.
PTN shares meropenem study data March 20, 2015To help improve the knowledge base for pediatric medicine, the PTN is pleased to share data from its meropenem study with interested investigators. Information about the study and how to obtain the data is available on the website.
Baby TAPE activates first site February 27, 2015Penn State Milton S. Hershey Medical Center became the first site activated to enroll patients into the Baby TAPE study this week.
Weight is the foremost marker of health and health outcomes in infants. For infants receiving care in a neonatal intensive care unit, however, it can be nearly impossible to remove or account for the ...
PTN to present findings at PAS 2015 February 19, 2015Researchers will be presenting results from PTN studies at the annual meeting of the Pediatric Academic Societies, to be held April 25-28, 2015, in San Diego. Presenters will include:
M. Smith et al., Pharmacokinetics of Multiple-Dose Intravenous Clindamycin in Obese Children (poster)
J. Momper et al., Population Pharmacokinetics of Fluconazole in Extremely Low Birth Weight Infants (platform)