NCT00431418

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2007

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

3.5 years

First QC Date

February 2, 2007

Last Update Submit

September 21, 2015

Conditions

Lung Diseases

Outcome Measures

Primary Outcomes (1)

  • Length of ventilation

    12 months after completion of study

Secondary Outcomes (1)

  • Bronchopulmonary Dysplasia (BPD)

    12 months after completion of study

Study Arms (2)

1

ACTIVE COMPARATOR

Sildenafil oral solution.

Drug: Sildenafil

2

PLACEBO COMPARATOR

Placebo oral solution.

Drug: Placebo

Interventions

SildenafilDRUG

Sildenafil oral solution

Also known as: Revatio(R)
1
PlaceboDRUG

Placebo solution

2

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Congenital heart defects
  • Suspected inborn error of metabolism
  • Inhaled Nitric Oxide treatment during assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mercy Hospital for Women

Heidelburg, Victoria, 3084, Australia

Location

MeSH Terms

Conditions

Lung Diseases

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Neonatologist

Study Record Dates

First Submitted

February 2, 2007

First Posted

February 5, 2007

Study Start

January 1, 2007

Primary Completion

July 1, 2010

Study Completion

June 1, 2012

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

AU(1)