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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00431418

Enrollment

Registered

2007-02-05

Start date

2007-01-31

Completion date

2012-06-30

Last updated

2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases

Brief 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.

Interventions

DRUGSildenafil

Sildenafil oral solution

DRUGPlacebo

Placebo solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

No minimum to 7 Days

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Length of ventilation	12 months after completion of study

Secondary

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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026