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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Mercy Hospital for Women, Australia
ClinicalTrials.gov Identifier:
NCT00431418
First received: February 2, 2007
Last updated: August 3, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention Phase
Lung Diseases
 Drug: Sildenafil
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease (SPICE Trial): a Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by Mercy Hospital for Women, Australia:

Primary Outcome Measures:
  • Length of ventilation [ Time Frame: 12 months after completion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bronchopulmonary Dysplasia (BPD) [ Time Frame: 12 months after completion of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2007
Estimated Study Completion Date: June 2012
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Kai Konig, Mercy Hospital for Women
ClinicalTrials.gov Identifier: NCT00431418     History of Changes
Other Study ID Numbers: R 06/34
Study First Received: February 2, 2007
Last Updated: August 3, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
 Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013