Bronchopulmonary Dysplasia (BPD) Clinical Trial
Official title:
Efficacy and Safety of No Treatment Compared With Oral Ibuprofen Treatment for Patent Ductus Arteriosus in Preterm Infants: a Randomized, Double-blind, Placebo-controlled, Non-inferiority Clinical Trial
NCT number | NCT02128191 |
Other study ID # | 2013-07-129 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | July 2014 |
Est. completion date | August 2019 |
Verified date | January 2020 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 142 |
Est. completion date | August 2019 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 14 Days |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of moderate to severe bronchopulmonary dysplasia (BPD) or mortality at 36 weeks postmenstrual age (PMA) | 36 weeks PMA | ||
Secondary | Incidence of moderate to severe BPD | 36 weeks PMA | ||
Secondary | Incidence of oxygen dependency at 40 weeks PMA | 40 weeks PMA | ||
Secondary | Mortality rate | 28-days since birth and 36 weeks PMA | ||
Secondary | incidence of intraventricular hemorrhage (grade 3 or greater) | 28-days since birth | ||
Secondary | Incidence of retinopathy of prematurity (stage III or greater) | 40 weeks PMA (± 2 weeks) | ||
Secondary | Incidence of necrotizing enterocolitis (stage 2b or greater) | 40 weeks PMA (± 2 weeks) | ||
Secondary | Duration of PDA | 40 weeks PMA (± 2 weeks) | ||
Secondary | Duration of intubation | 36 weeks PMA | ||
Secondary | Duration of nasal continuous positive airway pressure (NCPAP) treatment | 40 weeks PMA (± 2 weeks) | ||
Secondary | Cumulative duration of oxygen use | 40 weeks PMA (± 2 weeks) | ||
Secondary | Incidence of adverse events | participants will be followed for the duration of hospital stay, an expected average of 12 weeks | ||
Secondary | Growth velocity | 40 weeks PMA (± 2 weeks) |
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