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
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