None listed
Conditions
Interventions
Drug : The experimental group is intravenously injected with azithromycin 10 mg / kg / dose q 24 hr for 1 week, followed by 5 mg / kg / dose q 24 hr for 1 week, and the placebo control group is intrav
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? 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.
Exclusion criteria
Exclusion criteria: ? 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bronchopulmonary dysplasia or death | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Korea, Republic of
Contacts
Public ContactEuiseok Jung
Asan Medical Center
Outcome results
None listed