IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Persistent Pulmonary Hypertension of the Newborn

Interventions

SildenafilDRUG

Loading dose of 0.1 mg/kg for 30 minutes followed by maintenance treatment of 0.03 mg/kg.h for up to 14 days

Eligibility

Sex: ALLMax age: 72 Hours

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Efficacy - incidence of treatment failure

Time frame: Day 1-14

Need for inhaled nitric oxide or Extracorporeal membrane oxygenation

Time frame: Day 1-14

Secondary Outcomes

Changes in oxygenation index

Time frame: 6 & 12 hours

Changes in differential saturation

Time frame: 6 & 12 hours

Duration of mechanical ventilation

Time frame: Days 1-14

Time from initiation of sildenafil to inhaled nitric oxide or extracorporeal membrane oxygenation

Time frame: Days 1-14

Data from ClinicalTrials.gov

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