Back to resultsThe Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease
Primary Purpose
Lung Diseases
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Sildenafil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lung Diseases
Eligibility 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
Sites / Locations
- Mercy Hospital for Women
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Sildenafil oral solution.
Placebo oral solution.
Outcomes
Primary Outcome Measures
Length of ventilation
Secondary Outcome Measures
Bronchopulmonary Dysplasia (BPD)
Full Information
NCT ID
NCT00431418
First Posted
February 2, 2007
Last Updated
September 21, 2015
Sponsor
Mercy Hospital for Women, Australia
1. Study Identification
Unique Protocol Identification Number
NCT00431418
Brief Title
The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease
Official Title
The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease (SPICE Trial): a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mercy Hospital for Women, Australia
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Sildenafil oral solution.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo oral solution.
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Other Intervention Name(s)
Revatio(R)
Intervention Description
Sildenafil oral solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo solution
Primary Outcome Measure Information:
Title
Length of ventilation
Time Frame
12 months after completion of study
Secondary Outcome Measure Information:
Title
Bronchopulmonary Dysplasia (BPD)
Time Frame
12 months after completion of study
10. Eligibility
Sex
All
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai König, MD
Organizational Affiliation
Mercy Hospital for Women
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles P Barfield, MD
Organizational Affiliation
Mercy Hospital for Women
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chad C Andersen, MD
Organizational Affiliation
Mercy Hospital for Women
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Hospital for Women
City
Heidelburg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease
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