Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia.

• Status: Not yet recruiting
• Trial end date: 2026-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to determine whether intratracheal administration of budesonide combined with surfactant, as compared to surfactant alone, will modify ecographic (lung ultrasound score) and biological markers (IL-6 concentration in respiratory secretions) at 7 days of life in preterm infants ≤32 weeks of gestational age (GA).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Clinic of Barcelona
• Treatments: Budesonide; Poractant alfa

Criteria

Inclusion Criteria:

• Infants born equal or earlier than 32 weeks of gestational age admitted in the Neonatal Intensive Care Unit.

• Parental consent signed.

• Less than or equal to 48 hours postnatal age.

Exclusion Criteria:

• Infants with known major congenital anomalies (eg. congenital upper airwayobstruction, congenital lung anomaly, severe pulmonary hypoplasia, hydrops,neuromuscular diseases, chromosomopaties)

• Infants with poor prognosis and risk of imminent death

• Infants who have received the first dose of surfactant before of the enrolment to the study.