The purpose of this study is to evaluate the efficacy and safety of no treatment compared with ibuprofen treatment for patent ductus arteriosus in preterm infants. The study hypothesis is that no treatment is not inferior to oral ibuprofen treatment in preterm infants. (non-inferiority study)
This study is a randomized, double-blind, placebo-controlled, non-inferiority clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
142
Initial dose of 10 mg/kg of oral ibuprofen, followed by two doses of 5 mg/kg 24 and 48 hours later
Initial dose of normal saline followed by second and third dose 24 and 48 hours later, at equal volume to ibuprofen arm
Samsung Medical Center
Seoul, South Korea
Incidence of moderate to severe bronchopulmonary dysplasia (BPD) or mortality at 36 weeks postmenstrual age (PMA)
Time frame: 36 weeks PMA
Incidence of moderate to severe BPD
Time frame: 36 weeks PMA
Incidence of oxygen dependency at 40 weeks PMA
Time frame: 40 weeks PMA
Mortality rate
Time frame: 28-days since birth and 36 weeks PMA
incidence of intraventricular hemorrhage (grade 3 or greater)
Time frame: 28-days since birth
Incidence of retinopathy of prematurity (stage III or greater)
Time frame: 40 weeks PMA (± 2 weeks)
Incidence of necrotizing enterocolitis (stage 2b or greater)
Time frame: 40 weeks PMA (± 2 weeks)
Duration of PDA
Time frame: 40 weeks PMA (± 2 weeks)
Duration of intubation
Time frame: 36 weeks PMA
Duration of nasal continuous positive airway pressure (NCPAP) treatment
Time frame: 40 weeks PMA (± 2 weeks)
Cumulative duration of oxygen use
Time frame: 40 weeks PMA (± 2 weeks)
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Incidence of adverse events
Time frame: participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Growth velocity
Time frame: 40 weeks PMA (± 2 weeks)