Official Title: “The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease (SPICE Trial): a Pilot Study”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2009

Intervention(s) in this Clinical Trial

• Drug: Sildenafil
  • Sildenafil oral solution
• Drug: Placebo
  • Placebo solution

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Sildenafil
• Placebo Comparator: 2
  • Placebo solution

Primary Measures

• Length of ventilation
  • Time Frame: after patient enrolment
    Safety Issue?: No

Secondary Measures

• BPD
  • Time Frame: after patient enrolment
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 7 Days

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Mercy Hospital for Women, Australia

Overall Clinical Trial Officials and Contacts

Kai König, MD Principal Investigator Mercy Hospital for Women  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00431418

Study ID Number: R 06/34

ClinicalTrials.gov Identifier: NCT00431418

Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration