The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease

Mercy Hospital for Women, Australia20 enrolled

Overview

The purpose of this pilot study is to investigate in a randomised double-blind trial whether treatment with Sildenafil reduces duration of ventilatory support in preterm infants born at 28 weeks of gestation or less.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Lung Diseases

Interventions

SildenafilDRUG

Sildenafil oral solution

PlaceboDRUG

Placebo solution

Eligibility

Sex: ALLMax age: 7 Days

Medical Language ↔ Plain English

Inclusion Criteria: * Newborn babies born \<28 weeks of gestation who still need ventilatory support via endotracheal tube or have been re-ventilated at day 7 of life. Exclusion Criteria: * Congenital heart defects * Suspected inborn error of metabolism * Inhaled Nitric Oxide treatment during assessment

Locations (1)

Mercy Hospital for Women

Heidelburg, Victoria, Australia

Outcomes

Primary Outcomes

Length of ventilation

Time frame: 12 months after completion of study

Secondary Outcomes

Bronchopulmonary Dysplasia (BPD)

Time frame: 12 months after completion of study

Data from ClinicalTrials.gov

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