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Completed

NCT Number: NCT00431418

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

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.

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Key information

Conditions

Lung Diseases Respiratory Tract Diseases

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mercy Hospital for Women

Heidelburg, Victoria, 3084, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sildenafil

Drug

Sildenafil oral solution

Other names: Revatio(R)

Placebo

Drug

Placebo solution

Primary outcomes

  1. Length of ventilation

    Time frame: 12 months after completion of study

Secondary outcomes

  1. Bronchopulmonary Dysplasia (BPD)

    Time frame: 12 months after completion of study

Sponsors and collaborators

Lead sponsor

Mercy Hospital for Women, Australia

Other

Registry information

Official study title

The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease (SPICE Trial): a Pilot Study

Important dates

Study start
2007
Primary completion
2010
Study completion
2012
First posted
Feb 5, 2007
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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