PTN News

  • Digoxin study achieves substantial milestone May 31, 2020 The PTN digoxin study has achieved more than 20% of participant enrollment goals and has activated all sites. The study, which enrolled the first participant in the summer of 2019, will determine the pharmacokinetics (how a drug travels through the body) and safety of digoxin prescribed to infants with single ventricle congenital heart disease (CHD). While digoxin has been ...
  • POP02 begins study enrollment May 26, 2020 The Pediatric Trials Network (PTN) has started enrolling participants in the Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care (POP02) study. POP02 aims to expand upon the work done as part of PTN POPS, with hopes to shrink the gap between pediatric and adult dosing information available to prescribing ...
  • NIH funding opportunity for PTN consultative resources May 12, 2020 The National Institutes of Health (NIH) has released a funding opportunity announcement (FOA) that will help investigators obtain access to consultative resources through the Pediatric Trials Network (PTN) and the Best Pharmaceuticals for Children Act (BPCA) Data Coordinating Center. The primary goal is to aid researchers in the planning phase of single or multi-site, investigator initiated ...
  • Database locked for Levetiracetum as part of AED study April 30, 2020 The Pediatric Trials Network (PTN) has locked the database for Levetiracetam, one drug included in the Pharmacokinetics (PK) of Anti-epileptic Drugs in Obese Children (AED) study. “With this study, the PTN and its sites have addressed the important, but under recognized problem of how obesity impacts drug pharmacokinetics in children.   It can be hoped that the ...
  • PTN assists in learning more about potential COVID-19 treatment drugs April 28, 2020 In record speed, the Pediatric Trials Network (PTN) worked to collaboratively and successfully stand up an extended component of the Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care (POP02) to focus on six drugs that have the potential to be involved in the treatment of COVID-19. The drugs ...
  • PTN’s Clindamycin research informs FDA label change March 30, 2020 The U.S. Food and Drug Administration (FDA) has updated the prescribing information, or drug label, of Clindamycin, based on data provided by the Pediatric Trials Network (PTN). The updated label now includes dosing guidelines for children with obesity. “Sometimes in children with obesity, the way the body absorbs and processes drugs is different than in other ...
  • PTN CUDDLE achieves study milestone March 26, 2020 PTN’s study (NICHD-2017-BMS01) of Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants (CUDDLE,) has completed study enrollment for nine off-patent drugs; marking a substantial milestone in determining the safety of drugs passed through breastmilk. The study, which began in 2018, has enrolled approximately 50 lactating women, per drug, along with their ...
  • PTN’s Caffeine, Doxycycline research results in two new FDA label changes March 18, 2020 Research conducted by the Pediatric Trials Network (PTN) has led the U.S. Food and Drug Administration (FDA) to update the prescribing information, or drug label, of two medications: Caffeine citrate and Doxycycline. Caffeine citrate is the most commonly used non-antimicrobial medications for premature infants used in the in the newborn intensive care unit. When given to ...
  • Mercy babyTAPE approved for marketing October 21, 2019 The U.S. Food and Drug Administration (FDA) has approved marketing of Mercy babyTAPE. Developed by PTN’s Dr. Susan Abdel-Rahman of Children’s Mercy Hospital, the Mercy babyTAPE device is intended for use by health care professionals to estimate the body weight of infants from birth to 90 days of age. “Weight is the foremost marker of health ...
  • New project supports inclusion of children with Down syndrome in clinical trials October 2, 2019 The Pediatric Trials Network (PTN) has received an award to contribute to the National Institutes of Health’s (NIH) INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) project. The INCLUDE directive calls for a trans-NIH research initiative to address critical health and quality-of-life needs for individuals with Down syndrome across the lifespan. One ...

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