Lung Diseases Clinical Trial
Official title:
The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease (SPICE Trial): a Pilot Study
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 2012 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 7 Days |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Mercy Hospital for Women | Heidelburg | Victoria |
Lead Sponsor | Collaborator |
---|---|
Mercy Hospital for Women, Australia |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Length of ventilation | 12 months after completion of study | No | |
Secondary | Bronchopulmonary Dysplasia (BPD) | 12 months after completion of study | No |
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