Pediatric Trials Network

  • PTN Research Informs Fluconazole Label Change February 16, 2024

    Data from multiple Pediatric Trials Network (PTN) studies contributed to a recent U.S. Food and Drug Administration (FDA) label change for fluconazole. The data that informed the label update, ...

  • Dumela Botswana! PTN Research on Breastfeeding Looks at Antiretroviral Medications January 22, 2024

    The Pediatric Trials Network (PTN) said “Dumela” (hello in Setswana) to Botswana as it activated a Botswana-based site in January. The site has already enrolled several participants in the Pharmacokinetic and Safety of Antiretroviral and Related Drugs in Lactating Women and Breastmilk Fed Infants (BMS02) study. This study will help answer important questions about breastfeeding for women living with HIV/AIDS around the ...

FDA Label Changes

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
  • Levetiracetam
  • Lisinopril
  • Lithium
  • Lorazepam
  • Mercy babyTAPE
  • 2D and 3D Mercy TAPE
  • Meropenem
  • Propylthiouracil
  • Pralidoxime
  • Rifampin
  • Sodium nitroprusside
  • Fluconazole

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REFLECTIONS ON PEDIATRIC CLINICAL RESEARCH

The Pediatric Trials Network (PTN) partnered with the International Children’s Advisory Network (iCAN) to produce an anthology that highlights iCAN members’ perspectives on the pediatric clinical research process. A formal publication will eventually be produced as a way of engaging families in the clinical research process. Take a look at some of the submissions received thus far.

 

Results At-A-Glance

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 all stakeholders through result summaries. We appreciate every family who participates in research and makes this work possible.

Acyclovir Results-At-A-Glance 

Ampicillin Results-At-A-Glance 

Lisinopril Results-At-A-Glance 

Meropenem Results-At-A-Glance

POP01 Results-At-A-Glance

Caffeine Citrate Results-At-A-Glance

babyTAPE Results-At-A-Glance

PPE Results-At-A-Glance

Metronidazole Results-At-A-Glance

Clindamycin Results-At-A-Glance

Ticarcillin-clavulanate Results-At-A-Glance

Evidence Into Practice
The leader in pediatric research of off-patent drugs

The PTN provides pediatricians, researchers, and regulators with new information on how children respond to medications. Studies are conducted primarily with off-patent drugs that are lacking data on safety, efficacy, and dosing in pediatric populations. The primary goal is to generate the data necessary to produce evidence-based clinical practice guidelines.