Clinical Trials Logo
  1. Home
  2. Lung Diseases
  3. NCT00431418
  4. Details
NCT00431418 Clinical Trial

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

Lung Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00431418
Other study ID # R 06/34
Secondary ID
Status Completed
Phase Phase 3
First received February 2, 2007
Last updated September 21, 2015
Start date January 2007
Est. completion date June 2012

Study information
Verified date September 2015
Source Mercy Hospital for Women, Australia
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date June 2012
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group N/A to 7 Days
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Sildenafil
Sildenafil oral solution
• Placebo
Placebo solution

Locations
Country Name City State
Australia Mercy Hospital for Women Heidelburg Victoria

Sponsors (1)
Lead Sponsor Collaborator
Mercy Hospital for Women, Australia

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Length of ventilation 12 months after completion of study No
Secondary Bronchopulmonary Dysplasia (BPD) 12 months after completion of study No
See also
  Status Clinical Trial Phase
Completed NCT05563701 - Evaluation of the LVivo Image Quality Scoring (IQS)
Completed NCT04908397 - Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension Phase 1
Terminated NCT03309358 - A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis Phase 1
Completed NCT03682354 - ESPB Versus INB With PCIA in Video-assisted Thoracic Surgery N/A
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Completed NCT03626519 - Effects of Menthol on Dyspnoea in COPD Patients N/A
Recruiting NCT06004440 - Real World Registry for Use of the Ion Endoluminal System
Completed NCT04874948 - Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment Phase 1
Completed NCT02926768 - Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors Phase 1
Completed NCT01443845 - Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS) Phase 4
Terminated NCT00233207 - IC14 Antibodies to Treat Individuals With Acute Lung Injury Phase 2
Completed NCT00281216 - Innate and Adaptive Immunity in Individuals Experiencing Chronic Obstructive Pulmonary Disease Exacerbations N/A
Completed NCT00269256 - Stress, Environment, and Genetics in Urban Children With Asthma N/A
Recruiting NCT00129350 - Assessment of Heart and Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation Phase 1
Active, not recruiting NCT00115297 - Montelukast for Early Life Wheezing Phase 2/Phase 3
Completed NCT00094276 - Intervention for Improving Asthma Care for Minority Children in Head Start N/A
Completed NCT00091767 - Genetic Studies in Difficult to Treat Asthma: TENOR N/A
Completed NCT00089752 - Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea N/A
Completed NCT00069823 - Study of Acid Reflux in Asthma Phase 3
Completed NCT00083798 - Family Linkage Study of Obstructive Sleep Apnea (OSA) in Iceland N/A