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

Phase 3

Completed

• Conditions: Lung Diseases
• Interventions: Drug: Placebo; Drug: Sildenafil

• Registration Number: NCT00431418
• Lead Sponsor: Mercy Hospital for Women, Australia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-02-02
• Study First Submitted QC: 2007-02-02
• Study First Posted: 2007-02-05
• Primary Completion: 2010-07
• Study Completion: 2012-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo oral solution.
1	Sildenafil	Sildenafil oral solution.

Primary Outcome Measures

Name	Time	Method
Length of ventilation	12 months after completion of study

Secondary Outcome Measures

Name	Time	Method
Bronchopulmonary Dysplasia (BPD)	12 months after completion of study

Trial Locations

Locations (1)

Mercy Hospital for Women; 🇦🇺 Heidelburg, Victoria, Australia