Status:
NOT_YET_RECRUITING
Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia.
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Bronchopulmonary Dysplasia
Respiratory Distress Syndrome in Premature Infant
Eligibility:
All Genders
Up to 48 years
Phase:
PHASE3
Brief 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 bio...
Detailed Description
Bronchopulmonary dysplasia (BPD) is one of the main morbidities associated with extreme prematurity and, despite the improvement of respiratory care in the latest years, overall incidence is not decre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04862377
Start Date
October 1 2021
End Date
April 1 2026
Last Update
September 13 2021
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