Overview

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

Status:
Unknown status

Trial end date:
2013-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

East Carolina University

Treatments:

Budesonide
Calfactant

Criteria

Inclusion Criteria:

1. Birth weight 501-1000 g and ≤ 28 weeks gestational age

2. Diagnosed as RDS requiring mechanical ventilation and surfactant therapy during the
first 4 hours after birth

3. Still ventilated on day 5-9 of life.

4. An interval of at least 24 hours' duration between the last dose of indomethacin and
the endotracheal instillation of study drug.

Exclusion Criteria:

1. Congenital or chromosomal anomalies

2. Occurrence of perinatal sepsis

3. Use of intravenous steroids > 7 days