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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Mercy Hospital for Women, Australia.
Recruitment status was  Active, not recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014