Bronchopulmonary Dysplasia Clinical Trial
Official title:
Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome.
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.
A randomized double bind controlled trial, designed to evaluate the addition of budesonide to
poractant alfa to prevent bronchopulmonary dysplasia (BPD) in preterm infants with
respiratory distress syndrome (RDS).
The usual treatment of RDS includes ventilatory support and exogenous surfactant, however, a
cronic lung disease known as BPD, is a complication found in many of these patients.
BPD is a complex disease occurring in preterm infants recovering from RDS and inflammation
plays a key role in its physiopathology.
Animal derived surfactants have demonstrated to decrease the incidence of BPD, and porcine
surfactant (poractant alfa) has and increased effect compared with bovine surfactant
(beractant).
Budesonide is an inhaled anti-inflammatory steroid that has shown to reduce BPD when combined
with beractant by decreasing lung inflammation, without secondary systemic effects, when
combined with poractant alfa it could enhance even more this anti-inflammatory effect.
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