Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04862377
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-09-13
First Post:
2021-03-05
Brief Title:
Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Efficacy and Safety of the Intratracheal Administration of Budesonide With Porcine Pulmonary Surfactant in Very Preterm Infants to Prevent Bronchopulmonary Dysplasia Randomized Clinical Trial BuS Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BuS
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 biological markers IL-6 concentration in respiratory secretions at 7 days of life in preterm infants 32 weeks of gestational age GA
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 decreasing Etiology of BPD is multifactorial and local inflammation plays an important role in it therfore local anti-inflammatory drugs could be effective in preventing BPD
Recent randomised trials have shown a lower incidence of BPDdeath with the use of a combination of budesonide with surfactat compared to surfactant alone and further clinical trials are currently ongoing
This is a controlled phase IV randomised unicenter clinical trial designed to evaluate the effect of intratracheal administration of budesonide combined with surfactant as compared to surfactant alone in BPD in preterm infants 32 weeks of GA Investigators will compare ecographic and biological markers as well as respiratory outcomes
Recent randomised trials have shown a lower incidence of BPDdeath with the use of a combination of budesonide with surfactat compared to surfactant alone and further clinical trials are currently ongoing
This is a controlled phase IV randomised unicenter clinical trial designed to evaluate the effect of intratracheal administration of budesonide combined with surfactant as compared to surfactant alone in BPD in preterm infants 32 weeks of GA Investigators will compare ecographic and biological markers as well as respiratory outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None