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

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 Overview

• Status: Completed
• Conditions: Lung Diseases
• Intervention / Treatment: Drug: Placebo; Drug: Sildenafil

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Heidelburg, Victoria, Australia, 3084
      • Mercy Hospital for Women

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 week (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Sildenafil oral solution.	Drug: Sildenafil; Sildenafil oral solution; Other Names: Revatio(R)
Placebo Comparator: 2; Placebo oral solution.	Drug: Placebo; Placebo solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Length of ventilation	12 months after completion of study

Secondary Outcome Measures

Outcome Measure	Time Frame
Bronchopulmonary Dysplasia (BPD)	12 months after completion of study

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: February 2, 2007
• First Submitted That Met QC Criteria: February 2, 2007
• First Posted (Estimate): February 5, 2007

Study Record Updates

• Last Update Posted (Estimate): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 21, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: R 06/34