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

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ClinicalTrials.gov Identifier: NCT00431418
Recruitment Status : Completed
First Posted : February 5, 2007
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Kai Konig, Mercy Hospital for Women, Australia

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.

Condition or disease Intervention/treatment Phase
Lung Diseases Drug: Sildenafil Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease (SPICE Trial): a Pilot Study
Study Start Date : January 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Sildenafil oral solution.
Drug: Sildenafil
Sildenafil oral solution
Other Name: Revatio(R)
Placebo Comparator: 2
Placebo oral solution.
Drug: Placebo
Placebo solution



Primary Outcome Measures :
  1. Length of ventilation [ Time Frame: 12 months after completion of study ]

Secondary Outcome Measures :
  1. Bronchopulmonary Dysplasia (BPD) [ Time Frame: 12 months after completion of study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00431418


Locations
Australia, Victoria
Mercy Hospital for Women
Heidelburg, Victoria, Australia, 3084
Sponsors and Collaborators
Mercy Hospital for Women, Australia
Investigators
Principal Investigator: 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

Responsible Party: Dr. Kai Konig, Consultant Neonatologist, Mercy Hospital for Women, Australia
ClinicalTrials.gov Identifier: NCT00431418     History of Changes
Other Study ID Numbers: R 06/34
First Posted: February 5, 2007    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Pharmaceutical Solutions
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents