Intra-tracheal Instillation of Budesonide to Prevent Chronic Lung Disease

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Preterm infants are randomized to received either Intra-tracheal instillation of budesonide using surfactant as vehicle or a placebo. Intra-tracheal instillation of budesonide using surfactant as vehicle would facilitate its delivery to the periphery of the lung and would inhibit lung inflammation and mitigate acute lung injury.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arizona
• Treatments: Budesonide; Pulmonary Surfactants

Criteria

Inclusion Criteria:

• Infants born at < 30+0/7 weeks (23+0 - 29+6/7) gestational age (GA) OR with preterm infants with a birth weight (BW) which is < 1500 gm AND if they have severe respiratory distress syndrome (RDS) (Clinical diagnosis based on the need for mechanical ventilation in preterm infant or if they have radiologic features of RDS along with need for positive distending airway pressure and fractional inspired oxygen (FiO2) > 0.3)

Exclusion Criteria:

1. major congenital defects

2. chromosomal abnormality

3. pneumothorax

4. Known surgical disease

5. Known or suspected congenital heart disease

6. Infant not considered viable by physician

7. Severe sepsis / infections

8. Likely to be extubated within the next 24 hours