The Efficacy and Safety of Azithromycin in Preventing Bronchopulmonary Dysplasia in Ureaplasma-positive Preterm Infants
- Conditions
- Certain conditions originating in the perinatal period
- Registration Number
- KCT0002373
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 56
? A premature infant born at the Asan Medical Center in Seoul with birth weight less than 1,500 g or less than 32 weeks of gestational age
? A positive result of ureaplasma test (culture or PCR test in gastric juice or tracheal aspirate and nasopharyngeal aspirate) performed after birth (within 30 minutes to 24 hours)
? Oxygen partial pressures of 0.4 or more, or ventilator-assisted infant (conventional ventilator, high frequency oscillatory ventilator, synchonized noninvasive positive pressure ventilation, noninvasive positive pressure ventilation, nasal continuous positive airway pressure, bubble continuous positive airway pressure, heated humidified high-flow nasal cannula)
? Parents who have voluntarily participated in this trial have voluntarily signed their written consent.
? When accompanied by major congenital anomalies
? When the collection of specimens for research is impossible due to respiratory failure
? When there is QT interval extension on ECG (QTc> 450 ms)
? If it is judged by researchers that it is difficult to carry out the clinical trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bronchopulmonary dysplasia or death
- Secondary Outcome Measures
Name Time Method Bronchopulmonary dysplasia;Ureaplasma eradication rate (culture, PCR);Cytokine(IL-1b, IL-6, IL-10) level;Oxygen use rate, systemic steroid administration rate, weight gain rate, hospitalization period;Frequency and severity of adverse events and serious adverse events;Vital signs, laboratory tests and physical examinations