Status:
COMPLETED
Intratracheal Budesonide/Surfactant Prevents BPD
Lead Sponsor:
Taipei Medical University
Collaborating Sponsors:
Taipei Medical University Hospital
National Taiwan University Hospital
Conditions:
Respiratory Distress Syndrome
Bronchopulmonary Dysplasia
Eligibility:
All Genders
30-4 years
Phase:
PHASE4
Brief Summary
A double-blind study includes: 1) birth Wt 500-1499 gm, 2) respiratory distress shortly after birth and requires resuscitation 3) failure to NCPAP within 4 hrs after birth, defined as: a) FIO2 ≥ 0.30,...
Detailed Description
A double-blind study will be conducted in 7 tertiary centers. Inclusion criteria are: 1) birth Wt 500-1499 gm, 2) respiratory distress shortly after birth and requires resuscitation 3) failure to NCPA...
Eligibility Criteria
Inclusion
- 1\) birth Wt 500-1499 gm, 2) respiratory distress shortly after birth and requires resuscitation, 3) failure to NCPAP within 4 hrs after birth, defined as: a) FIO2 ≥ 0.30, pressure \> 5 cmH2O b) severe retraction c) apnea d) PCO2 ≥ 60 mmHg.
Exclusion
- 1\) lethal cardiopulmonary status, 2) severe congenital anomalies.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT03275415
Start Date
July 1 2019
End Date
June 30 2022
Last Update
May 30 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Taiwan University Hospital
Taipei, Taiwan