Remodulin for the treatment of Persistent Pulmonary Hypertension of the Newborn (PPHN)

IRB
CHLA-16-00033
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

To explore the safety and treatment effect of intravenous (IV) Remodulin as add on therapy in neonates with PPHN compared to placebo.

Study Details
Clinical Trials Government Identifier
NCT02261883
Keywords
treprostinil remodulin, persistent pulmonary hypertension, pulmonary hypertension, PPHN
Study Type
Randomized
Eligibility

1.) Subjects will be at least 34 weeks gestational age, 2 kg at screening and have a diagnosis of PPHN
2.) 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
Does this study also recruit healthy volunteers?
No
Enrollment Status
Closed
Coordinator Contact
Sharon Tang
Contact Email
shatang@chla.usc.edu