drugset / Trial / NCT04019106
Budesonide With Intratracheal Surfactants in Extremely Preterm Infants
Phase 1/2
Unknown
30 enrolled
University of Manitoba
BLES Biochemicals Inc. · collabHealth Sciences Centre, Winnipeg, Manitoba · collabManitoba Institute of Child Health · collabSt. Boniface Hospital · collabUniversity of Utah · collabWinnipeg Rh Institute Foundation Inc. · collab
Non-randomizedSequentialOpen-labelPrevention
Summary
This is a phase I/II trial in preterm infants aimed at identifying the optimal dose of budesonide with bovine lipid extract surfactant as vehicle for intratracheal administration.
Timeline
- Start
- 2019-10-15
- Primary completion
- 2020-10-15
- Completion
- 2021-01-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Budesonide | Small molecule | 0.0625 mg/kg | Intrathecal |
| Subject | Budesonide | Small molecule | 0.125 mg/kg | Intrathecal |
| Subject | Budesonide | Small molecule | 0.25 mg/kg | Intrathecal |
| Background | Bovine Lipid Extract Surfactant | Unknown | 5 ml | Intrathecal |