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

Mercy Hospital for Women, Australia

Status and phase: Completed; Phase 3

Conditions: Lung Diseases

Treatments: Drug: Placebo; Drug: Sildenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT00431418

R 06/34

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: Under 7 days old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Sildenafil oral solution.

Treatment:

Drug: Sildenafil

2

Placebo Comparator group

Description:

Placebo oral solution.

Treatment:

Drug: Placebo