PTN News

  • 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 ...
  • PTN timolol study completes patient enrollment September 26, 2019 The Pediatric Trials Network (PTN) has enrolled the last patient in its Efficacy, Safety and Pharmacokinetics of Topical Timolol in Infants with Infantile Hemangioma (TIM01) study. In the study, approximately 110 participants will be randomized to either 0.25% or 0.5% timolol for 180 days to determine the most appropriate dosing level for children younger than three ...
  • First participant enrolled in digoxin study September 5, 2019 The PTN digoxin study achieved a major study milestone by enrolling its first participant. The study team aims to enroll up to 48 infants to 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 approved by the ...
  • Sildenafil safety study achieves major milestone August 28, 2019 The Pediatric Trials Network (PTN) recently enrolled the fortieth infant in the Safety of Sildenafil in Premature Infants study. This is a major study milestone, as it rounds out the first cohort (or group of study participants). The study aims to assess the safety of sildenafil in premature infants at risk of bronchopulmonary dysplasia (BPD) and ...
  • iCAN 2019 summit helps inform pediatric clinical research July 30, 2019 The annual International Children’s Advisory Network (iCAN) Summit took place June 24-28 in Kansas City, Mo. Representatives from the Pediatric Trials Network (PTN) were in attendance, along with global representatives from pharmaceutical and clinical research groups. The mission of iCAN is to empower pediatric patients worldwide by providing children and families a voice in health, research, ...
  • Investigator shares successes, lessons learned from PTN, IDeA States partnership July 9, 2019 During a PTN-hosted symposium at the Pediatric Academic Societies (PAS) Annual Meeting on Sunday, April 28, Dr. Janice Sullivan of the University of Louisville School of Medicine discussed the successes and lessons learned from the IDeA States Pediatric Clinical Trials Network’s (ISPCTN) participation in the PTN POPS Study. The ISPCTN is one component of ECHO (Environmental ...

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