THE EFFECT OF NEBULIZED AZITHROMYCIN AS AN ADJUVANT PREVENTIVE THERAPY FOR BRONCHOPULMONARY DYSPLASIA IN PRETERM INFANTS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Development of BPD (bronchopulmonary dysplasia)
研究概览
简要总结
The aim of the study is to determine the effectiveness of nebulized azithromycin therapy in prevention of BPD in very low birth weight preterm infants when compared with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age less than 32 weeks and birth weight less than 1500 g.
- •Infants who are still in need of respiratory support at day 7 of life (intubated, or by non-invasive mechanical ventilation, including CPAP and high-flow nasal cannula, or any form of oxygen therapy).
排除标准
- •Gestational age ≥ 32 weeks.
- •Newborns with congenital cyanotic heart diseases.
- •Obvious major congenital malformations, known syndromes or chromosomal anomalies.
- •Infants with signs compatible with the diagnosis of necrotizing enterocolitis (NEC) in the first week of life.
- •Current use of steroids.
研究组 & 干预措施
Group I : Azithromycin group
Patients will receive nebulized azithromycin (Xithrone, Amoun, Egypt) that will be initiated from day 7 of birth in a dose of 20 mg/kg/day in two divided doses for 3 weeks till the time of primary outcome assessment (at 28 days of age).
干预措施: Azithromycin neubilization (Drug)
Group I : Azithromycin group
Patients will receive nebulized azithromycin (Xithrone, Amoun, Egypt) that will be initiated from day 7 of birth in a dose of 20 mg/kg/day in two divided doses for 3 weeks till the time of primary outcome assessment (at 28 days of age).
干预措施: Lung ultrasound (Device)
Group II: conventional treatment group
Patients will not receive the medication, instead will receive 3 ml of nebulized normal saline as placebo control.
干预措施: Lung ultrasound (Device)
结局指标
主要结局
Development of BPD (bronchopulmonary dysplasia)
时间窗: 28 days of life and/or 36 weeks postmenstrual age
Developed BPD :Yes or No If patient fulfilled criteria of BPD ; patient is born at or less than 32 weeks gestational age and still need oxygen and or respiratory support at the 28 day or more postnatal age and/or 36 weeks postmenstrual age.
Lung Ultrasound assessment
时间窗: 14 days postnatal age.
Lung ultrasound score The score is calculated by the following points at different lung zones using lung ultrasound 0: A lines 1. 3 or more nonconfluent B lines 2. confluent B lines 3. C profile or consolidation
次要结局
未报告次要终点
研究者
Marwa Mohamed Farag
Assistant professor of pediatrics at Alexandria University
Alexandria University