Overview

Intratracheal Budesonide/Surfactant Prevents BPD

Status:
Unknown status

Trial end date:
2020-08-31

Target enrollment:
0

Participant gender:
All

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, pressure > 5cmH2O b) severe retraction c) apnea d) PCO2 ≥ 60 mmHg. Exclusion criteria: 1) lethal cardiopulmonary status 2) severe congenital anomalies. Sample size will be determined based on a one-third (33%) improvement of the current incidence of BPD or death in the selected population (from 50%→33%), allowing a type I error 0.05, type II error 0.10 (power 0.90), 182 infants in each group would be needed and 190 in each group would be a safe target number. The infants will be randomly assigned to control (C) (Curosurf/placebo) or intervention (I) (Curosurf/budesonide); given q. 12 hrs for a maximum of 3 doses unless the infant is extubated or require FIO2 <30%. Appropriate amount of placebo will be used as it does not affect the biophysical property of curosurf (PAS abstract 2017 San Francisco) Primary outcome of study is death or BPD defined by NICHD criteria. Follow up study of neuromotor and cognitive function and pulmonary states will be done at 1-2 years of corrected age.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Taipei Medical University

Collaborators:

Chang Gung Memorial Hospital
China Medical University Hospital
Chung Shan Medical University
Mackay Memorial Hospital
National Taiwan University Hospital
Taipei Medical University Hospital
Taipei Veterans General Hospital, Taiwan

Treatments:

Budesonide
Pulmonary Surfactants

Criteria

Inclusion Criteria:

- 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 Criteria:

- 1) lethal cardiopulmonary status, 2) severe congenital anomalies.