Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia.

• Status: Unknown status
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the addition of budesonide to poractant alfa to prevent bronchopulmonary dysplasia in preterm infants with respiratory distress syndrome. Half of the participants will receive budesonide and poractant alfa in combination, and the other half will receive poractant alfa with saline.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Central "Dr. Ignacio Morones Prieto"
• Collaborator: Universidad Autonoma de San Luis Potosí
• Treatments: Budesonide; Poractant alfa

Criteria

Inclusion Criteria:

• Birth weight <1500g

• Gestational age ≥ 26 weeks

• Respiratory distress syndrome that requires exogenous surfactant at birth or in the first 12 hours of life.

Exclusion Criteria:

• Major congenital anomalies.

• Perinatal asphyxia

• Respiratory depression secondary to general anesthesia.