Trial II of Lung Protection With Azithromycin in the Preterm Infant
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Incidence of Bronchopulmonary Dysplasia (BPD)
研究概览
简要总结
The hypothesis of this study is that administration of azithromycin to ventilated premature infants will decrease the incidence and severity of BPD.
The purpose of this study is to determine if Azithromycin treatment is beneficial for prevention of bronchopulmonary dysplasia in preterm infants.
详细描述
The survival of preterm infants has increased dramatically and has been associated with an increase in BPD. The incidence of BPD among extremely low birthweight infants ranges from 45% to 90%. Development of BPD is associated with both antenatal (maternal chorioamnionitis often due to Ureaplasma is related to BPD) and postnatal complications (oxygen toxicity, barotrauma, late onset infections). These insults appear to lead to an inflammatory response with resultant arrest of normal alveolar and vascular development. Multiple human studies support the role of inflammation in the development of BPD.
Evaluating a medication that could decrease the inflammation in BPD, with minimal side effects, could significantly improve the morbidities of prematurity and the financial burden incurred by parents. Macrolide antibiotics (erythromycin and azithromycin) have been shown to have anti-inflammatory properties that are independent of their antimicrobial properties.
Azithromycin has the potential to decrease the severity of ventilator-induced pulmonary inflammation that is commonly seen in BPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •birthweight less than 1250 grams admitted to UK NICU
- •mechanical ventilation within the first 72 hours of life
排除标准
- •confirmed sepsis by blood culture
- •multiple congenital anomalies or known syndromes
- •intrauterine growth retardation with birthweight less than 10%ile for gestational age
- •ROM for >7 days
研究组 & 干预措施
Azithromycin Group
Group receives azithromycin
干预措施: Azithromycin (Drug)
Placebo Group
Group receives placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Bronchopulmonary Dysplasia (BPD)
时间窗: diagnosis of BPD at 36wks corrected gestational age
comparison of the % Incidence of bronchopulmonary dysplasia (BPD) for the azithromycin vs placebo groups.
次要结局
未报告次要终点
研究者
Hubert Ballard
Principal Investigator
University of Kentucky