drugset / Trial / NCT01268215

Pilot Study of Topical Steroid for Prevention of Chronic Lung Disease in Extremely Premature Infants.

NCT01268215

Phase 2 Unknown 45 enrolled East Carolina University
RandomizedParallel-groupQuadruple-blindPrevention

Summary

A Pilot study to evaluate the safety and the efficacy of endotracheal instillation of pulmonary surfactant, with or without topical steroid (Budesonide), as a prophylactic treatment for Bronchopulmonary Dysplasia (a form of chronic lung disease) in extremely low birth weight infants. Cytokines (a group of inflammatory mediators) are measured in the tracheal aspirate before and after instillation of the study drugs.

Timeline

Start
2010-07
Primary completion
2012-06
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule Other
Subject Calfactant Protein / enzyme biologic Other