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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease (SPICE Trial): a Pilot Study|
- Length of ventilation [ Time Frame: 12 months after completion of study ] [ Designated as safety issue: No ]
- Bronchopulmonary Dysplasia (BPD) [ Time Frame: 12 months after completion of study ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||June 2012|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Sildenafil oral solution.
Sildenafil oral solution
Other Name: Revatio(R)
Placebo Comparator: 2
Placebo oral solution.
|Mercy Hospital for Women|
|Heidelburg, Victoria, Australia, 3084|
|Principal Investigator:||Kai König, MD||Mercy Hospital for Women|
|Principal Investigator:||Charles P Barfield, MD||Mercy Hospital for Women|
|Principal Investigator:||Chad C Andersen, MD||Mercy Hospital for Women|