We aimed to compare the efficacy and safety of azithromycin and placebo in patients with premature infants whose birth weight was less than 1,500 g or gestational age of less than 32 weeks and were reported to be positive for ureaplasma. From the time of deliberation of the instituitional review board until March 8, 2018, it will proceed with single institution, prospective, randomized, control and parallel design clinical trial. The study group consisted of 56 subjects (28 subjects in the test group and 28 subjects in the control group). The test group was administered azithromycin 10 mg / kg / dose q 24 hr for 1 week followed by 5 mg / kg / dose q 24 hr for 1 week. The aim of this study was to evaluate the primary efficacy of bronchopulmonary dysplasia and mortality according to the presence and severity of oxygen therapy at 36 weeks gestational age (or discharge). Ureaplasma eradication rates (culture, PCR) using the airway or nasopharyngeal aspirates before and 2 weeks after drug administration were compared between the experimental group and the placebo group. The systemic steroid administration rate, body weight gain rate, cytokine (IL-1b, IL-6, and IL-10) levels with ELISA technique were also compared between groups.The frequency and severity of adverse events and serious adverse events, as well as signs of vital signs, laboratory tests, and physical examinations, are evaluated to evaluate safety at the same time.

Prevention

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 intravenously injected with the equivalent amount of normal saline as the experimental drug for 2 weeks.

Arm Label

Target Number of Participant

Arm Type

Arm Description

The experimental group is given azithromycin 10 mg / kg / dose q 24 hr for 1 week, followed by 5 mg / kg / dose q 24 hr for 1 week

Arm Label

Target Number of Participant

Arm Type

Arm Description

The placebo control group is given an equivalent amount of normal saline for 2 weeks.

Gender

Age

Description

① 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
② 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)
③ 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)
④ Parents who have voluntarily participated in this trial have voluntarily signed their written consent.

① When accompanied by major congenital anomalies
② When the collection of specimens for research is impossible due to respiratory failure
③ When there is QT interval extension on ECG (QTc> 450 ms)
④ If it is judged by researchers that it is difficult to carry out the clinical trial

Bronchopulmonary dysplasia or death

Gestational age 36 weeks or death

Bronchopulmonary dysplasia

Gestational age 36 weeks or discharge

Ureaplasma eradication rate (culture, PCR)

Before and after administration of 2 weeks of drug administration 

Cytokine(IL-1b, IL-6, IL-10) level

Before and after administration of 2 weeks of drug administration 

Oxygen use rate, systemic steroid administration rate, weight gain rate, hospitalization period

at discharge

Frequency and severity of adverse events and serious adverse events

During the study period

Vital signs, laboratory tests and physical examinations

During the study period