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...
Brief Summary
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: July 2010
Intervention(s) in this Clinical Trial
- Drug: Sildenafil
- Sildenafil oral solution
- Drug: Placebo
- Placebo solution
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Sildenafil oral solution.
- Placebo Comparator: 2
- Placebo oral solution.
Outcome Measures for this Clinical Trial
Primary Measures
- Length of ventilation
- Time Frame: 12 months after completion of study
Safety Issue?: No
- Time Frame: 12 months after completion of study
Secondary Measures
- Bronchopulmonary Dysplasia (BPD)
- Time Frame: 12 months after completion of study
Safety Issue?: No
- Time Frame: 12 months after completion of study
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: 7 Days
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Mercy Hospital for Women, Australia Other
Overall Clinical Trial Officials and Contacts
Kai König, MD Principal Investigator Mercy Hospital for Women
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00431418
Study ID Number: R 06/34
ClinicalTrials.gov Identifier: NCT00431418
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00431418
