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Overview of the PTN

The Pediatric Trials Network (PTN) is made possible by the Best Pharmaceuticals for Children Act (BPCA). The BPCA, enacted in 2002, provides mechanisms for studying on- and off-patent drugs in children.

Meet PTN principal investigator Danny Benjamin, MD, PhD, MPH, and learn more about the network.

 Danny Benjamin, MD, PhD, MPH

An Introduction to the Pediatric Trials Network

The History of Pediatric Drug Research

 

 
Breaking News

Click here to find out what's new with PTN trials

March 14, 2014: SCAMP takes off

February 11, 2014: Check out the latest PTN Post

January 17, 2014: BPCA study leads to pediatric label change

January 16, 2014: Methadone study enrolls first patient

January 13, 2014: One child's appreciation for research


What is the PTN?

Sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the Pediatric Trials Network (PTN) is an alliance of clinical research sites located around the United States that are cooperating in the design and conduct of pediatric clinical trials to improve health care for the youngest patients.

Children are not simply "little adults" who respond to drugs according to scale. Rather, developing organs and changes in metabolism throughout infancy and childhood affect how drugs are processed by immature or maturing bodies. Thus, special care must be taken in tailoring the use of medicines in this unique and vulnerable population. Unfortunately, only a small percentage of drugs and devices approved by the Food and Drug Administration are actually labeled for pediatric use. Pediatricians, consequently, are often forced to prescribe medical therapies "off-label," or according to their best guess based on adult studies.

To fill this troubling information gap, the PTN is studying the formulation, dosing, efficacy, and safety of drugs, as well as the development of medical devices, used in pediatric patients. In keeping with the goals of the Best Pharmaceuticals for Children Act, data collected from PTN trials will help regulators to revise drug labels for safer and more effective use in infants and children.


Where is the PTN?

Click on the map image below to view an interactive map with detailed site information.

Site map 5/3/12


PTN Trial Status Updates

Here's what's happening with PTN trials in progress and what's on the horizon.

 

Trial
Status
Enrollment and analysis completed, clinical study report submitted to FDA, results published
Enrollment completed in less than 2 months, results published
Enrollment complete, analysis in progress, results published
Enrollment completed
Enrollment ongoing
Enrollment completed
Data analysis in progress
Data collection and analysis completed
Analysis in progress
Enrollment ongoing
Enrollment ongoing, interim PK analysis
Enrollment ongoing
Meta-analysis ongoing
Midazolam obesity
Protocol in development
Protocol complete, opening sites
Protocol complete, selecting sites
Protocol complete, analysis ongoing
Protocol complete, selecting sites
Protocol complete, opening sites
Enrollment ongoing

 


Projects and Methods

Learn more about PTN projects and methods from the investigators:

 

Michael Smith 

Michael J. Smith, MD, MS

Clindamycin Dosing in Obese Children

 

 Adriana Tremoulet, MD

Adriana Tremoulet, MD

The Ampicillin in Infants Study

 

Kathleen Neville, MD, MS

Kathleen Neville, MD, MS

Hydroxyurea in Pediatric Patients with Sickle Cell Anemia

 

Micky Cohen-Wolkowiez

Micky Cohen-Wolkowiez, MD, PhD

An Overview of the POPS Study

 

Mario Sampson

Mario Sampson, PharmD

Dried Blood Spot Sampling

 

P. Brian Smith, MD, MPH, MHS

P. Brian Smith, MD, MPH, MHS

An Open-label Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants