Trial | NCT00431418  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    sildenafil ...

  • Study Participants

    20
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 Started
Jan 31
2007
Primary Completion
Jul 31
2010
Study Completion
Jun 30
2012
Last Update
Sep 23
2015
Estimate

Drug Sildenafil

Sildenafil oral solution

  • Other names: Revatio(R)

Drug Placebo

Placebo solution

1 Active Comparator

Sildenafil oral solution.

2 Placebo Comparator

Placebo oral solution.

Criteria 

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
No Results Posted