The Effect of Sildenafil in Preterm Infants With Evolving... | NCT00431418

Studies
The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease

NCT00431418

Sponsor

Mercy Hospital for Women, Australia

Status

Completed

Last Update Posted

Sep 23, 2015Estimated

Enrollment

20Actual

Phase

Phase 3

Conditions

Lung Diseases

Interventions

Sildenafil
Placebo

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Jul 2010Actual

Completion Date

Jun 2012Actual

First Submitted Date

Feb 2, 2007

First Submission Date that Met QC Criteria

Feb 2, 2007

First Posted Date

Feb 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2015

Last Update Posted Date

Sep 23, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Kai Konig, Consultant Neonatologist, Mercy Hospital for Women, AustraliaPrincipal Investigator

Lead Sponsor

Mercy Hospital for Women, AustraliaOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Sildenafil oral solution.	Drug: Sildenafil
2	Placebo Comparator	Placebo oral solution.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sildenafil	Drug	Sildenafil oral solution	1	Revatio(R)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of ventilation		12 months after completion of study

Secondary Outcomes

Measure	Description	Time Frame
Bronchopulmonary Dysplasia (BPD)		12 months after completion of study

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

7 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mercy Hospital for Women		Heidelburg	Victoria	3084	Australia

ID	Term
D008171	Lung Diseases

ID	Term
D012140	Respiratory Tract Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D000068677	Sildenafil Citrate

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D013450	Sulfones
D013457

Browse Leaves

Not provided

Browse Branches

Not provided