NCT05534685 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Gharehbaghi MM, Mhallei M, Ganji S, Yasrebinia S
The efficacy of intratracheal administration of surfactant and budesonide combination in the prevention of bronchopulmonary dysplasia. J Res Med Sci. 2021 May 27;26:31. doi: 10.4103/jrms.JRMS_106_19. eColl
Tang W, Chen S, Shi D, Ai T, Zhang L, Huang Y, Fan Y, Du Y
Effectiveness and safety of early combined utilization of budesonide and surfactant by airway for bronchopulmonary dysplasia prevention in premature infants with RDS: A meta-analysis. Pediatr Pul

To Compare the Effect of Intratracheal Administration of Surfactant vs. Surfactant/Budesonide on the Incidence of Bronchopulmonary Dysplasia in Preterm Infants Less Than 34 Weeks of Gestation

Details for clinical trial NCT05534685

Clinical trial NCT05534685 - References