CHLA Clinical Research Studies

Having volunteers participate in research studies and clinical trials is critical to our research efforts. Thousands of children and families are involved in our patient-centered studies every year. Many of the treatments used today are based on the results of past research studies and clinical trials conducted with our patients. Our scientific and clinical experts take the best ideas from the laboratory -- to the patient -- in the form of promising new treatments.

By searching our study directory, you may identify research that could impact the life of your child or of another child you know. Because the number of available research studies and clinical trials for children nationwide is small, every participant makes a significant contribution.

In addition to enrolling children with certain diseases in order to study treatments and prevention of those diseases, we also need to study healthy children. Ask your child’s doctor about volunteer study options that may be suitable for your child.

Please contact the study staff listed in your search results for more information.

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Study Details - ID: CHLA-16-00033
Health/Science/Disease Category:
Treatment of Persistent Pulmonary Hypertension of the Newborn (PPHN)
Short Name:
Remodulin for the treatment of PPHN
Full Title of Study:
Intravenous Remodulin (Treprostinil) as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn: A Randomized, Placebo-Controlled, Safety and Efficacy Study
Phase/Type of Study:
Randomized, double-blind, placebo-controlled, multi-center, comparative study: Phase II
Purpose of Research:
To explore the safety and treatment effect of intravenous (IV) Remodulin as add on therapy in neonates with PPHN compared to placebo.
Eligibility:
Eligible subjects will be at least 34 weeks gestational age, 2 kg at screening and have a diagnosis of PPHN. The subject must have two consecutive OIs of 15 or greater, separated by at least 30 minutes, after having received iNO for at least 3 hours prior to randomization and initiation of study drug.
Time Commitment/Requirements:
14-day treatment period. However, subjects with residual or chronic pulmonary hypertension that does not fully resolve within 14 days may continue to receive study drug for up to an additional 14 days (up to 28 days total). Post-treatment data will be collected until death, time of hospital discharge, time of withdrawal from study, or for 4 weeks after last dose of study drug, whichever comes first.
Primary Investigator:
Philippe Friedlich
Coordinator Contact Name:
Dana Fine
Phone Number:
323-361-5088
Email:
dafine@chla.usc.edu
Clinical Trials .Gov Identifier:
NCT02261883