Vanderbilt Clinical Trials

A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn

Purpose

This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide treatment and reduce the failure rate of available treatments for persistent pulmonary hypertension of the newborn.

Condition

Pulmonary Hypertension, Familial Persistent, of the Newborn

Eligibility

Eligible Ages: Between 0 Days and 4 Days
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Neonates with persistent pulmonary hypertension of the newborn - Age <=96 hours and >=34 weeks gestational age - Oxygenation Index >15 and <60 - Concurrent treatment with inhaled nitric oxide and >=50% oxygen

Exclusion Criteria

Prior or immediate need for extracorporeal membrane oxygenation or cardiopulmonary resuscitation - Expected duration of mechanical ventilation <48 hours - Profound hypoxemia - Life-threatening or lethal congenital anomaly

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Placebo Comparator placebo	iv placebo of normal saline or 10% dextrose	Drug: placebo IV placebo or 0.9% sodium chloride or 10% dextrose. Infusion rate based on weight.
Experimental sildenafil	Active study drug	Drug: iv sildenafil loading dose of 0.1 mg/kg over 30 minutes followed by maintenance dose of 0.03 mg/kg/h. To infuse minimum 48 hours and maximum of 14 days. Other names: revatio

More Details

Status: Completed
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.