Issue 37 | July 2022

The second quarter of 2022 has been a busy one for the Pediatric Trials Network (PTN)! Our Project team was able to travel to France and participate in the annual iCAN Research and Advocacy Summit, we have continued to information label changes, and have met a number of study milestones.

Take a look at all the exciting highlights below and, as always, thank you for all you do to make drugs and devices safer and more effective for use in the youngest of patients. 

Raising Awareness for Pediatric Clinical Trials and Patient Engagement: PTN Presents at 2022 iCAN Research and Advocacy Summit

The Pediatric Trials Network (PTN) Project Team, along with global representatives from pharmaceutical and clinical research groups, recently participated in the annual International Children’s Advisory Network (iCAN) Research and Advocacy Summit in Lyon, France. More 

Under the Best Pharmaceuticals for Children Act (BPCA), the PTN works to provide the Food and Drug Administration (FDA) with information to inform label changes with the necessary information to prescribe the most appropriate doses of the medications to children. As a result of research conducted through the BPCA program, led by the PTN, the following label changes have been made:

• Acyclovir
• Ampicillin
• Caffeine
• Clindamycin (2)
• Diazepam
• Doxycycline
• Lisinopril
• Lithium
• Lorazepam
• Mercy babyTAPE
• 2D and 3D Mercy TAPE
• Meropenem
• Propylthiouracil
• Pralidoxime
• Sodium nitroprusside

Kenneth McCall III, a middle schooler and iCAN participant discusses the importance of PTN research. 

Most Recent Label Change:

Clindamycin Label Updated to Include Dosing Information for Premature and Term Infants

A Pediatric Trials Network (PTN) pharmacokinetic (PK) study recently contributed to a medication label change for the drug clindamycin.

This research effort, which involved analysis data from 4 studies (Pharmacokinetics of Antistaphylococcal Antibiotics in Infants, Pharmacokinetics of Understudied Drugs Administered to Children, and Safety and Pharmacokinetics of Multiple-Dose Intravenous and Oral Clindamycin, and Antibiotic Safety in Infants With Complicated Intra-abdominal Infections), determined the pharmacokinetics in premature and term infants for treatment of staphylococcal infections. More 

Safety of Sildenafil in Premature Infants Study to Open Third Cohort Soon 

The Pediatric Trials Network (PTN) plans to open the third and final cohort (or group of study participants), in the Safety of Sildenafil in Premature Infants study in the near future. A total of 80 premature infants have been enrolled in the study so far, into the first and second study cohorts. These first and second cohorts received 0.125 mg/kg and 0.5 mg/kg of sildenafil in order to determine the safety in premature infants. The third, and final, cohort will receive the highest dose of 1 mg/kg. More

Lay Summaries

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 lay summaries. We appreciate every family who participates in research and makes this work possible.

Acyclovir Lay Summary

Ampicillin Lay Summary

Lisinopril Lay Summary

Meropenem Lay Summary

POP01 Lay Summary