Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia.

Launched by HOSPITAL CLINIC OF BARCELONA · Apr 26, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment for premature infants who are at risk of developing a condition called bronchopulmonary dysplasia (BPD), which affects their lungs. Researchers want to find out if giving a combination of budesonide (a medication that reduces inflammation) and surfactant (a substance that helps keep the lungs open) directly into the lungs is more effective than giving surfactant alone. The study will measure how this treatment affects lung health and certain biological markers in the first week of life for infants born at or before 32 weeks of pregnancy.

To participate in this trial, infants must be admitted to the Neonatal Intensive Care Unit (NICU) and be less than 48 hours old. Parents will need to provide consent for their child to join. However, infants with serious congenital conditions or those who are not expected to survive will not be included. This trial is not currently recruiting participants, but it aims to help improve care for vulnerable premature infants in the future.

Gender

ALL

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.