Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia.

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 1, 2021

Primary Completion Date

April 1, 2024

Study Completion Date

April 1, 2026

Conditions
Bronchopulmonary DysplasiaRespiratory Distress Syndrome in Premature InfantPrematurity
Interventions
DRUG

Poractant Alfa Intratracheal Suspension [Curosurf]

"Poractant alfa (Curosurf®):~First dose of treatment: 200mg/Kg. Further doses (up to a total maximum of 3 within first 48 hours of life): 100mg/Kg."

DRUG

Budesonide 0.5 MG/ML

"Poractant alfa (Curosurf®) + Budesonide nebulizer solution (Budesonida Aldo-Unión 0.5mg/mL suspensión para inhalación por nebulizador®):~First dose: 200mg/Kg of surfactant + 0.25mg/Kg of budesonide. Further doses (up to a total maximum of 3 within first 48 hours of life): 100mg/Kg of surfactant + 0.25mg/Kg of budesonide."

All Listed Sponsors
lead

Hospital Clinic of Barcelona

OTHER

NCT04862377 - Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia. | Biotech Hunter | Biotech Hunter