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

Viatris

Status and phase: Completed; Phase 3

Conditions: Pulmonary Hypertension, Familial Persistent, of the Newborn

Treatments: Drug: placebo; Drug: iv sildenafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01720524

2012-002619-24 (EudraCT Number)

A1481316

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: Under 4 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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59 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

iv placebo of normal saline or 10% dextrose

Treatment:

Drug: placebo

sildenafil

Experimental group

Description:

Active study drug

Treatment:

Drug: iv sildenafil