IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn

Viatris

Status and phase: Withdrawn; Phase 2

Conditions: Persistent Pulmonary Hypertension of the Newborn

Treatments: Drug: Sildenafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01360671

PPHN MIRROR STUDY

A1481294

Details and patient eligibility

About

To determine the efficacy of iv sildenafil in term and near term infants with PPHN (persistent pulmonary hypertension of the newborn), by measuring the need for inhaled nitric oxide (iNO) or extracorporeal membrane oxygenation (ECMO) compared to a historical control group not treated with sildenafil.

Sex: All

Ages: Under 72 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Babies < 72 hours old and at least 34 gestational weeks with PPHN or hypoxic respiratory failure associated with idiopathic PPHN, meconium aspiration, sepsis or pneumonia
• Oxygenation index >15 and < 60

Exclusion criteria

• Congenital anomaly
• Large left to right intracardiac or ductal shunt
• Already on inhaled nitric oxide

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Sildenafil

Experimental group

Description:

iv sildenafil

Treatment:

Drug: Sildenafil