Prevention of Chronic Lung Disease (CLD) in Preterm Infants -A New Therapeutic Regimen
试验速览
- 阶段
- 4 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Chronic lung disease morbidity among the survival
研究概览
简要总结
Pulmonary inflammation plays an important role in the early development of CLD. Postnatal glucocorticoids have been shown effective in the prevention or treatment of CLD with various success. However, systemic glucocorticoid therapy often associated with various short term and long term complications. Therefore, modification of the therapeutic regimen is needed. Inhaled steroid, including inhaled budesonide,have been tried but the results are essentially unsuccessful, most likely due to small airways that the inhaled steroid reaching to the peripheral lungs are limited and unpredictable. Direct instillation of budesonide into the airway has also shown to be ineffective, possibly due to poor distribution of steroid in the lungs.
The investigators hypothesize that intratracheal instillation of budesonide, a strong tropical steroid, using surfactant as vehicle would facilitate the delivery of budesonide to the lung periphery and would inhibit lung inflammation and improve the pulmonary outcome. The result of our pilot study (Pediatrics, 2008) indicated this high possibility.
详细描述
After informed consent is obtained, infant will be randomly assigned to two groups based on a double-blind design. Group I will receive surfactant and budesonide and GII will receive surfactant and air as control through endotracheal route. Therapy will be given every 8 hours until the infant require FIO2 < 30% or is extubated. The end point of assessment is the combined incidence of CLD and death judged at 36 weeks postconceptional age and the long term neurological and cognitive function at 2-3 years.
The incidence of CLD and death in the selective group of infant is about 60%. Using this 60% incidence in the placebo group and expected 40% (33% improvement) in the treated group, 130 infants in each group is needed to detected a difference, permitting a 5% chance of type I error and 10% chance of type II error. The total safe target number will be 300; 150 in each group. A collaborative study is therefore proposed. The primary outcome to be assessed is the combined incidence of CLD and death. The secondary outcome to be assessed is short term and long term side effects.
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Minutes 至 4 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant with birth weight between 500-1500 gram
- •Severe respiratory distress syndrome and requires mechanical ventilation with FIO2 > 60% shortly after birth
排除标准
- •Severe congenital anomalities
- •Lethal cardiopulmonary status at birth
研究组 & 干预措施
budesonide
The treatment group will receive surfactant and budesonide.
干预措施: budesonide (Drug)
surfactant and air
The placebo group will receive surfactant and air as control.
干预措施: surfactant and air (placebo) (Drug)
结局指标
主要结局
Chronic lung disease morbidity among the survival
时间窗: 36 postconceptional weeks
次要结局
- Neurodevelopment(2 years of age)