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

NCT ID: NCT00431418

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2012-06-30

Brief Summary

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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

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Conditions

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Lung Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Sildenafil oral solution.

Group Type ACTIVE_COMPARATOR

Sildenafil

Intervention Type DRUG

Sildenafil oral solution

2

Placebo oral solution.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo solution

Interventions

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Sildenafil

Sildenafil oral solution

Intervention Type DRUG

Placebo

Placebo solution

Intervention Type DRUG

Other Intervention Names

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Revatio(R)

Eligibility Criteria

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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
Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mercy Hospital for Women, Australia

OTHER

Sponsor Role lead

Responsible Party

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Dr. Kai Konig

Consultant Neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kai König, MD

Role: PRINCIPAL_INVESTIGATOR

Mercy Hospital for Women

Charles P Barfield, MD

Role: PRINCIPAL_INVESTIGATOR

Mercy Hospital for Women

Chad C Andersen, MD

Role: PRINCIPAL_INVESTIGATOR

Mercy Hospital for Women

Locations

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Mercy Hospital for Women

Heidelburg, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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R 06/34

Identifier Type: -

Identifier Source: org_study_id

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