Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00431418




Registration number
NCT00431418
Ethics application status
Date submitted
2/02/2007
Date registered
5/02/2007
Date last updated
23/09/2015

Titles & IDs
Public title
The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease
Scientific title
The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease (SPICE Trial): a Pilot Study
Secondary ID [1] 0 0
R 06/34
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Diseases 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sildenafil
Treatment: Drugs - Placebo

Active comparator: 1 - Sildenafil oral solution.

Placebo comparator: 2 - Placebo oral solution.


Treatment: Drugs: Sildenafil
Sildenafil oral solution

Treatment: Drugs: Placebo
Placebo solution
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Length of ventilation
Timepoint [1] 0 0
12 months after completion of study
Secondary outcome [1] 0 0
Bronchopulmonary Dysplasia (BPD)
Timepoint [1] 0 0
12 months after completion of study

Eligibility
Key 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.
Minimum age
No limit
Maximum age
7 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Congenital heart defects
* Suspected inborn error of metabolism
* Inhaled Nitric Oxide treatment during assessment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2012
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Mercy Hospital for Women - Heidelburg
Recruitment postcode(s) [1] 0 0
3084 - Heidelburg

Funding & Sponsors
Primary sponsor type
Other
Name
Mercy Hospital for Women, Australia
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00431418
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kai König, MD
Address 0 0
Mercy Hospital for Women
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00431418