Making drugs safer and more effective for use in the youngest populations.
Issue 40 | June 2023
Hello from the PTN,
We are halfway through 2023 and in a season of summer activities. In this issue of the PTN Post, we are excited to share some of the recent events happening within the PTN:
The PTN recently opened its third and final cohort of the Safety of Sildenafil in Premature Infants study. This is a major milestone to help determine the safety of a higher dose of sildenafil in premature infants at risk of bronchopulmonary dysplasia. Results from this study will be used to recommend the safest and most effective dosage.
In the spring, PTN investigators and collaborators, along with a patient advocate from the International Children’s Advisory Network (iCAN), held quick debates on topics related to pediatric clinical research. The event took place at the Pediatric Academic Societies Annual Meeting. PTN leadership also plans to attend the iCAN Summit in La Jolla, CA this July.
Dr. Matthew Laughon, a PTN investigator and neonatologist at the University of North Carolina at Chapel Hill shared his experience in his Investigator Spotlight.
A new Results-at-a-Glance Summary is available for a previously completed PTN study. It summarizes the methods and results of PTN studies evaluating health care providers’ ability to perform emergency pediatric tasks while wearing PPE.
We look forward to posting more Investigator Spotlights and Results-at-a-Glance summaries throughout the remainder of the year. Also, keep an eye out for updates about the five PTN studies that are ongoing and four that are enrolling soon.
We hope you have a great summer, and look forward to the second half of 2023. Thank you for your continued work toward making medications and devices safe and effective for all children.
The third cohort of PTN’s Safety of Sildenafil in Premature Infants study is now open. The study aims to assess the safety of sildenafil in premature infants at risk of bronchopulmonary dysplasia (BPD) and determine preliminary effectiveness and pharmacokinetics. The third, and final, cohort will receive the highest dose of sildenafil studied in this trial.
The PTN, with iCAN, sponsored a session at the Pediatric Academic Societies (PAS) Annual Meeting in Washington, D.C. this April. The session included quick debates between PTN investigators and collaborators on topics related to pediatric clinical research followed by comments from a patient advocate.
The PTN collaborates with several laboratories to develop and validate methods for analyzing biological samples. The PTN is now sharing these methods with the research community. The PTN Methods page contains a list of drugs studied by the PTN along with the type of biological sample (plasma, dried blood spot, urine, cerebrospinal fluid, and breastmilk) used to evaluate drug concentration. There are over 200 methods available for 90 drugs.
In his PTN Investigator Spotlight, Dr. Matt Laughon shares his experience as a neonatologist and conductor of clinical pharmacology studies in the NICU. He also describes a time he used a dosage of clindamycin that the PTN had recommended to treat an infant’s infection.
“PTN is committed to finding safe and effective drugs for children, and is an organization that also teaches and mentors thought leaders and other staff to conduct these critically important studies. My main goal is to improve the public health of infants and children, and the PTN goals precisely align with mine: to find safe and effective drugs.”
The Pediatric Trials Network works to make medications and medical devices 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 Result-at-a-Glance summaries. The most recently completed summary was on PTN’s personal protective equipment (PPE) studies. These studies evaluated health care workers’ ability to perform emergency pediatric care while wearing PPE.
PTN has five ongoing studies, four of which are enrolling and one that is in the follow-up phase. Pediatric participants of these studies range in age from infants to 21 years old, as well as breastfeeding mothers. Click the links below to learn more about each study.
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.
