Making drugs safer and more effective for use in the youngest populations.
Issue 35 | October 2021
Hello,
As we approach the end of 2021, the Pediatric Trials Network remains committed to learning more about COVID-19 in children. This year, the Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care (POP02) Study team has enrolled over 600 pediatric participants. As of September 2021, there are more than 400 SARS-CoV-2 participants and over 100 participants with multisystem inflammatory syndrome in children (MIS-C).
We have also continued to meet study milestones, such as our enrollment goal for the Digoxin study.
As always, thank you for your commitment to the PTN. We are grateful for the opportunity to partner with you as we make drugs safer and more effective for use in the youngest populations.
PTN remains committed to playing an active role in the response to COVID-19. From studying multi-inflammatory syndrome (MIS-C) in children, to updating the existing POP02 study to include participants with COVID, PTN has played an integral role in COVID-19 research.
The Pediatric Trial Network’s (PTN) Digoxin studyrecently reached the targeted enrollment goal for its study population of infants with Congenital Heart Disease (CHD). Thanks to the hard work and diligence of the clinical care team part of this study, including the PTN team, the target enrollment goal was timely and successfully met to move forward with collecting data from study participants.
The Pharmacokinetics and Safety Profile of Digoxin in Infants with Single Ventricle Congenital Heart Disease study is collecting safety and efficacy data on infants with single ventricle CHD to determine the appropriate dosing and safety measures of the study drug digoxin. Digoxin is approved by the U.S. Food and Drug Administration (FDA) to treat heart failure in patients with congenital heart disease. There has not been enough safety and efficacy data to determine proper dosing of this drug in pediatric patients with single ventricle CHD, which is what the PTN aims to change with this research effort. More
Lay Summaries
The Pediatric Trials Network works to make medication safer and more effective for all children. As part of that work, we share what we learn with research participants and the general public through lay summaries. We appreciate every family who participates in research and makes this work possible.
Have you heard? PTN has a new process for requesting access to samples and/or data from its studies for additional testing. An investigator must access data and samples directly from the NIH Data and Specimen Hub (DASH). Seethe PTN Data Sharing page for more information.
PTN is sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and provides pediatricians, researchers, and regulators with new information on how children respond to medications.
