A Message from the Lead Principal Investigator
|
|
Since our contract renewal in June, the PTN has been hard at work finding the safest and best dose of a variety of medications commonly used in children. We are enrolling participants in several studies, including our groundbreaking CUDDLE study to determine the safety of medications that are passed through breastmilk. We are also preparing to submit data to the FDA from our SCAMP study, which evaluates a number of antibiotics for treating complicated intra-abdominal infections in infants. In this issue, we’re also shining a spotlight on Paula Delmore, one of our dedicated study coordinators. Today and every day, we are grateful to Paula and all of our partners who work to make drugs safer and more effective for the smallest patients. Your care and enthusiasm make this essential work possible.
|
|
Danny Benjamin, MD, PhD, MPH
|
|
Database locked for SCAMP study
The PTN has locked the database for the Antibiotic Safety in Infants with Complicated Intra-abdominal Infections (SCAMP) study. The study aims to assess the safety, efficacy, and pharmacokinetics of three commonly prescribed antibiotic regimens for infants with complicated intra-abdominal infections, which are common and often fatal in premature infants. Nearly 300 infants participated in the study at 58 sites in the U.S. and Canada.
Read more
.
|
|
CUDDLE study enrolls first patient
The CUDDLE Study (Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants) enrolled its first patient on Thursday, Oct. 4, at Duke University Medical Center. Many thanks to site PI Dr. Brenna Hughes and site coordinator Kristin Weaver for their hard work. This groundbreaking study will track how different off-patent medications are passed through breastmilk to determine dosing levels that are safe for both mom and baby.
Read more
.
|
|
FDA changes lithium label to reflect appropriate dosing for children
The FDA recently updated the label for the drug lithium to include appropriate dosing for children. The change was made after a trial supported by
the
Eunice Kennedy Shriver
National Institute of Child Health and Human Development (NICHD)
showed that lithium was safe and effective for children with bipolar disorder. The
PTN was created by NICHD to make these types of pediatric trials more efficient.
Read more
on the NICHD website.
|
|
Applications open soon for STAR Program
The Summer Training in Academic Research (STAR) Program will begin accepting applications on Monday, Nov. 19. The annual eight-week program
,
which is led by PTN investigators and supported by NICHD
,
provides a high-quality, hands-on research experience for undergraduate students,
rising junior and senior
high school students, and middle and high school teachers during the summer academic break. Applications for summer 2019 will be accepted through Friday, Jan. 11.
Learn more
a
bout the program, or
read about the experience
of 2016 STAR graduate Daniel Gorham.
|
|
Paula Delmore (left) with Dr. Barry Bloom
|
|
Spotlight on Paula Delmore, Wesley Medical Center
Paula Delmore has actively participated in the support of clinical research for the past 30 years. Although the majority of her expertise is in the role of site study coordinator, she has served in the roles of multi-site coordinator, sub-investigator, and principal investigator. Her main strengths lie in her attention to detail and solid understanding of clinical trial execution in the neonatal area. Her team routinely performs as a highest enroller, which speaks to her exemplary coordination and good communication with providers, nursing staff, and families.
Read more
.
|
|
PTN prepares to conduct research on return-of-results summaries
The PTN is formalizing a process for sharing study findings with participants and caregivers and thanking them for their contributions to PTN studies. In early 2019, the PTN will begin gathering feedback from caregivers and adolescent participants on sample thank you notes and lay summaries of study findings. The PTN plans to use their input to establish best practices for providing thank you notes and lay summaries for all of its studies.
|
|
We want your stories!
If your involvement in PTN has had an impact on you, your career, or your care for patients, we want to hear from you. Please send an email to
PTN-Program-Manager@dm.duke.edu
to share your story. We may feature it on our website and in an upcoming newsletter!
|
|
Recruiting soon:
- Pharmacokinetics and Safety of Anesthetics and Analgesics in Children and Adolescents (ANA)
- Long-term Antipsychotic Pediatric Safety Trial (LAPS)
Currently enrolling:
- Pharmacokinetics of Anti-epileptic Drugs in Obese Children (AED)
- Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care (POPS)
- Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants (CUDDLE)
- Efficacy, Pharmacokinetics, and Safety of Topical Timolol in Infants with Infantile Hemangioma
- Safety of Sildenafil in Premature Infants at Risk of Bronchopulmonary Dysplasia
|
|
|
|
|
|
|