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

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Bronchopulmonary Dysplasia

In brief

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.

Key facts

Study ID

NCT01268215

Run by

East Carolina University

People needed

45

Starts

2010-07-01

Expected to finish

2013-12-01

Last updated by the study team

2010-12-29

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Birth weight 501-1000 g and ≤ 28 weeks gestational age
• Diagnosed as RDS requiring mechanical ventilation and surfactant therapy during the first 4 hours after birth
• Still ventilated on day 5-9 of life.
• An interval of at least 24 hours' duration between the last dose of indomethacin and the endotracheal instillation of study drug.

You may not qualify if…

• Congenital or chromosomal anomalies
• Occurrence of perinatal sepsis
• Use of intravenous steroids > 7 days

Where it is running

• NICU-Pitt County Memorial Hospital — Greenville, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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