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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.

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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
Enrollment completed in less than 2 months, results published

Acyclovir
Analyses complete, results published

Hydroxyurea
Enrollment completed

POPS
Enrollment ongoing

Lisinopril PK
Database locked, analyses complete, publication pending

Midazolam
Analyses in progress

Ampicillin
Analyses complete, results published

Obesity informatics
Analyses in progress

Anti-staph trio
Enrollment ongoing

Sildenafil
Enrollment ongoing, interim PK analysis

Clindamycin obesity
Database locked, final analyses in progress

Fluconazole safety
Meta-analyses ongoing, manuscript published

Acyclovir retrospective data collection
Enrollment ongoing

Pantoprazole
Enrollment ongoing

Pediatrix meta-analysis
Analyses ongoing

Antibiotic safety (SCAMP)
Enrollment ongoing

Diuretic safety
Analyses ongoing

Methadone pharmacokinetics
Enrollment complete

Baby TAPE
Enrollment ongoing

Caffeine
Data analysis ongoing

Furosemide
Protocol in draft