NCT01268215

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

The Effect of Endotracheal Instillation of Surfactant With and Without Budesonide on the Development of Bronchopulmonary Dysplasia in Ventilator-dependent, Extremely Low Birth Weight Infants: A Pilot Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: East Carolina University · Academic / Other
• Sex: All
• Age: 24 Weeks – 28 Weeks
• Healthy volunteers: Not accepted

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.

Detailed description

Bronchopulmonary Dysplasia (BPD) is still one of the most common complications of ventilated premature infants. Lung inflammation plays a major role in its pathogenesis. Systemic steroids can be given to control this inflammatory process but their widespread use is limited by their systemic side effects and concerns for long neurodevelopmental adverse sequelae. Delivering steroids by inhalation which has been proven to be effective in young infants with asthma has been shown to be unsatisfactory for ELBW infants with BPD. This may be due to the fact that current delivery devices do not meet the requirements of the specific anatomical and physiologic characteristics of the airways and breathing patterns in this special group of patients. A novel approach to facilitate delivery directly to the lungs, thereby avoiding systemic concerns has been demonstrated in a recent study in which budesonide ( a topical steroid) was given to ventilated preterm infants using surfactant as a vehicle.

Conditions

• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
DRUG	Infasurf	Endotracheal instillation of Infasurf once per week for three weeks
DRUG	Pulmicort	Endotracheal instillation, once per week for three weeks
OTHER	Sham	None instilled through the endotracheal tube

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-06-01
• Completion: 2013-12-01
• First posted: 2010-12-29
• Last updated: 2010-12-29

Locations

1 site across 1 country: United States