©2022 Stanford Medicine
Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn
Recruiting
I'm InterestedTrial ID: NCT02261883
Purpose
This study assessed the safety and treatment effect of intravenous (IV) Remodulin as an
add-on therapy in neonates with persistent pulmonary hypertension of the newborn (PPHN).
Official Title
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
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- Parent(s) or legal guardian provided consent for the subject to participate
- Weight at least 2 kg at Screening
- Gestational age of ≥34 weeks and ≤14 days old at Screening
- Diagnosis of PPHN, which was either idiopathic in nature or associated with the
following: meconium aspiration syndrome, pneumonia, respiratory distress syndrome,
sepsis, birth hypoxia, perinatal encephalopathy, or unilateral congenital
diaphragmatic hernia
- Currently requiring ventilator support
- Two consecutive oxygenation index (OI) of 15 or greater separated by at least 30
minutes, after receiving iNO for at least 3 hours
- Echocardiographic (ECHO) evidence of pulmonary hypertension with elevated right
ventricle pressure
- Dedicated venous access for the administration of study drug (central line or
peripherally inserted central venous catheter)
Exclusion Criteria:
- Previous or concurrent use of a phosphodiesterase-5 inhibitor, endothelin receptor
antagonist, or prostanoid
- Significant congenital heart disease as detected by ECHO, minor valvular
abnormalities, or expected transitional findings such as a patent foramen ovale, or
patent ductus arteriosus.
- Clinically significant, untreated active pneumothorax at Screening
- Evidence of clinically significant bleeding at Screening
- Necrotizing enterocolitis (≥Bells stage II at Screening)
- Uncontrolled hypotension (mean systemic pressures ≤35 mmHg at Screening)
- Uncontrolled coagulopathy and / or untreated thrombocytopenia (<50,000 platelets/µL at
Screening)
- History of severe (Grade 3 or 4) intracranial hemorrhage at Screening
- Currently receiving extracorporeal mechanical oxygenation (ECMO) or had immediate
plans to initiate ECMO
- Expected duration on mechanical ventilation of <48 hours
- Life expectancy was less than 2 months or had a lethal chromosomal anomaly
- Contraindication to ECMO
- Bilateral congenital diaphragmatic hernia
- Active seizures at Screening
- Currently participating in another clinical drug study
Intervention(s):
drug: IV Remodulin
drug: Placebo
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Keeley Phillips
650-723-8922