Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia. (BuS)
Bronchopulmonary Dysplasia, Respiratory Distress Syndrome in Premature Infant, Prematurity
About this trial
This is an interventional prevention trial for Bronchopulmonary Dysplasia focused on measuring Bronchopulmonary dysplasia, Respiratory Distress Syndrome in premature infant, Prematurity, Lung injury, Poractant alfa, Pulmonary surfactant, Budesonide, Anti-inflammatory agents, Glucocorticoids, Lung ultrasound, IL-6
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
No Intervention
Standard treatment group
Interventional treatment group
Control group
Infants randomised to the "standard treatment" arm will receive intratracheal surfactant as per usual clinical indications of respiratory distress syndrome in these preterm infants. In that sense, and based in those clinical indications, we have developed a risk calculator for surfactant administration in preterm infants ≤32 weeks GA. We will use it to decide what patients will receive surfactant (calculator available on: https://1drv.ms/x/s!Arjkl83HIXSngP8TWh8O6oi6Ztdw3w?e=gNCMxP).
Infants randomised to the "interventional treatment" arm will receive intratracheal surfactant mixed with budesonide. Indication of surfactant, as equal as for the "standard treatment" arm, will be decided using the calculator.
Infants ≤32 weeks with no indications for surfactant administration. Their clinical management will be the usual in our neonatal unit.