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Intra-tracheal Instillation of Budesonide Along With Surfactant in Preterm Infants to Prevent Chronic Lung Disease (STOPCLD)
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.
Details
| Lead sponsor | University of Arizona |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 25 |
| Start date | 2019-12-02 |
| Completion | 2024-12 |
Conditions
- Infant, Extremely Premature
- Acute Lung Injury
- Chronic Lung Disease of Prematurity
- Budesonide
Interventions
- Infants in the study group (S/B group) will receive surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL)
- Infants in the control group (S/P group) receive placebo (Normal saline 1mL)
Primary outcomes
- Change of combined inflammatory cytokines — 4 weeks
Change in inflammatory cytokines /chemokines (interleukin-6, 8, 10 and Tumor Necrosis Factor α (TNF-α) levels
Countries
United States