The objective of this study is to evaluate the efficacy and safety of a single intratracheal administration of Pneumostem® for treatment of Bronchopulmonary Dysplasia (BPD) in high-risk premature infants by comparing Pneumostem-treated group with a control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
69
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Incidence of BPD (moderate to severe) or mortality at 36 weeks PMA
Incidence of BPD (moderate to severe) or mortality rate at 36 weeks PMA
Time frame: 36 weeks PMA
Intubation duration
Time frame: 36 weeks PMA
Incidence of BPD
Time frame: 28-days since birth
Survival rate
Time frame: 28-days since birth, 36 weeks PMA, and termination of the trial
Duration of ventilator dependence
Time frame: Week 24
Duration of CPAP treatment
Time frame: Week 24
Postnatal steroid use (%) for the purpose of ventilator weaning
Time frame: Week 24
Cumulative duration of oxygen use
Time frame: Week 24
Incidence of Retinopathy of Prematurity (ROP) of Grade III or more
Time frame: Week 24
Retinopathy of Prematurity (ROP) that require treatment with avastin or laser
Time frame: Week 24
Growth velocity (Z-score)
Time frame: Week 24
Length of stay prior to the first discharge from the hospital
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Time frame: duration of the hospital stay, an expected average of approximately 3 months since birth
Incidence of adverse events
Time frame: Week 24
Clinically significant laboratory findings
Time frame: Week 24
Incidence of pneumothorax that require intubation
Time frame: Week 24
Incidence of moderate to severe pulmonary hemorrhage
Time frame: Week 24
Incidence of intraventricular hemorrhage of grade 3 or more
Time frame: Week 24