Our Impact

Informed Dosing = Better Care for Children

PTN research addresses knowledge gaps in the use of medications for pediatric patients. The PTN has submitted pediatric data for 21 products to the FDA. See a complete list of NIH-funded pediatric labeling changes.

Here we explore examples of some of the many ways in which PTN studies are informing better care:

Premature Infants

  • 1 in 10 US infants is born prematurely
  • Our research has shown that the smallest babies sometimes need higher medication doses due to their immature organs
  • PTN studies for this vulnerable population include
    • Preventive therapies for bronchopulmonary dysplasia, a chronic lung disease affecting ~17,000 US infants per year
    • Medications for potentially life-threatening infections

Children With Obesity

  • About 1 in 5 US children is considered obese
  • These patients are often excluded from clinical trials due to differences in the way their bodies handle drugs
  • A PTN systematic review found only 20 studies that have examined drug pharmacokinetics in obese children
  • Our studies evaluating dosing guidelines for obese children include
    • Antibiotics for methicillin-resistant Staphylococcus aureus (MRSA) infections, the leading cause of hospitalization among US children and adolescents
    • Antiseizure medications

Innovations in Pediatric Trial Design

Blood spotPTN trials employ advanced techniques that make it possible to efficiently and safely study medicines in the youngest patients with extremely limited blood volumes:

  • Advanced pharmacokinetic modeling
  • Cutting-edge blood sampling methods
  • Leftover samples from other laboratory tests
  • Mining existing clinical data

Every PTN study is closely examined to determine how to obtain the most valuable and generalizable results while minimizing the risk to participants.

Matthew Laughon, MD, MPH, of the University of North Carolina at Chapel Hill, discusses innovative clinical trial designs used in the Pediatric Trials Network.

Changing Practice

Physicians rely on treatment guidelines and reference materials to use the correct dose of medications for children. Through partnerships with the FDA and the American Academy of Pediatrics, evidence from PTN research is carried into product labeling and treatment guidelines, and ultimately, into the hands of physicians.


Results icon


quote box2

Meropenem, a broad-spectrum antimicrobial, was found to be a safe alternative for young infants with intra-abdominal infections, prompting a labeling change.

quote box 3

"These kids have been under-represented in studies for a very long time, and deserve to be included to make sure that we are prescribing medications thoughtfully and accurately."
Valentina Shakhnovich, MD
Children's Mercy Hospital