Bronchopulmonary Dysplasia (BPD)
Conditions
Keywords
Patent ductus arteriosus, Ibuprofen, Bronchopulmonary dysplasia
Brief summary
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)
Detailed description
This study is a randomized, double-blind, placebo-controlled, non-inferiority clinical trial.
Interventions
DRUGOral ibuprofen
Initial dose of 10 mg/kg of oral ibuprofen, followed by two doses of 5 mg/kg 24 and 48 hours later
DRUGNormal saline
Initial dose of normal saline followed by second and third dose 24 and 48 hours later, at equal volume to ibuprofen arm
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Days to 14 Days
Healthy volunteers
No
Inclusion criteria
1. gestational age of 30 weeks or less or birth weight of 1250 g or less 2. born in Samsung Medical Center 3. confirmed to have hemodynamically significant patent ductus arteriosus (PDA) during day of life (DOL) 5 to 14 4. Definition of hemodynamically significant PDA: ductal size ≥ 1.5 mm with left-to-right shunt (or bidirectional shunt with dominant left-to-right blood flow) on the initial echocardiography plus at least one of clinical criteria. * Clinical criteria * Respiratory signs, including tachypnea, chest retraction, increased respiratory support, unable to wean respiratory support * Physical signs, including a murmur, hyperdynamic precordium or bounding pulses * Blood pressure problems, including decreased mean or diastolic pressure or increased pulse pressure * Signs of congestive heart failure, including cardiomegaly, hepatomegaly or pulmonary congestion
Exclusion criteria
* Mortality within the first 48 hours of life * Ductal size \< 1.5 mm on the initial echocardiography * Right-to-left shunt or bidirectional shunting with dominant right-to-left shunt through PDA * congenital anomaly * bilateral intraventricular hemorrhage of grade 4 * contraindication of ibuprofen (bleeding diasthesis, platelet count 10,000/mm3 or less, serum creatinine 2.0 mg/dL or greater, necrotizing enterocolitis stage 2 or greater
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of moderate to severe bronchopulmonary dysplasia (BPD) or mortality at 36 weeks postmenstrual age (PMA) | 36 weeks PMA |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of retinopathy of prematurity (stage III or greater) | 40 weeks PMA (± 2 weeks) |
| Incidence of necrotizing enterocolitis (stage 2b or greater) | 40 weeks PMA (± 2 weeks) |
| Duration of PDA | 40 weeks PMA (± 2 weeks) |
| Duration of intubation | 36 weeks PMA |
| Incidence of moderate to severe BPD | 36 weeks PMA |
| incidence of intraventricular hemorrhage (grade 3 or greater) | 28-days since birth |
| Mortality rate | 28-days since birth and 36 weeks PMA |
| Duration of nasal continuous positive airway pressure (NCPAP) treatment | 40 weeks PMA (± 2 weeks) |
| Cumulative duration of oxygen use | 40 weeks PMA (± 2 weeks) |
| Incidence of adverse events | participants will be followed for the duration of hospital stay, an expected average of 12 weeks |
| Growth velocity | 40 weeks PMA (± 2 weeks) |
| Incidence of oxygen dependency at 40 weeks PMA | 40 weeks PMA |
Countries
South Korea
Outcome results
None listed