Welcome to PTN

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What Is 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 PTN?

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

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PTN Trial Status Updates

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

Metronidazole
Analyses complete; clinical study report submitted to FDA, results published

TAPE
Analysis complete; clinical study report submitted to FDA, results published

Acyclovir
Analyses complete; clinical study report submitted to FDA, results published

Hydroxyurea
Analyses complete; clinical study report submitted to FDA

POPS
Enrollment ongoing

Lisinopril PK
Analyses complete; publication pending; Clinical study report submitted to FDA

Midazolam
Analyses in progress

Ampicillin
Analyses complete; clinical study report submitted to FDA, results published

Obesity informatics
Analyses complete; results published

Anti-staph trio
Enrollment closed

Sildenafil
Enrollment ongoing; interim PK analysis in progress

Clindamycin obesity
Analyses complete; clinical study report submitted to FDA

Fluconazole safety
Meta-analyses ongoing; clinical study report submitted to FDA; results published

Acyclovir retrospective data collection
Enrollment ongoing

Pantoprazole
Enrollment complete

Pediatrix meta-analysis
Analyses complete; results published: January 2015, May 2015, and July 2015

Antibiotic safety (SCAMP)
Enrollment ongoing

Diuretic safety
Analyses complete; clinical study report submitted to FDA

Methadone pharmacokinetics
Enrollment closed

Baby TAPE
Enrollment is closed; database is locked.

Caffeine
Data analysis ongoing

Furosemide
Enrollment ongoing

Timolol
Protocol in draft

Anti-epileptic Obesity
Protocol in draft

Trimethoprim-sulfamethoxazole and clindamycin
Data analysis ongoing