The Effect of Endotracheal Instillation of Surfactant With and Without Budesonide on the Development of Bronchopulmonary Dysplasia in Ventilator-dependent, Extremely Low Birth Weight Infants: A Pilot Study
试验速览
- 阶段
- 2 期
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- To measure the effect of surfactant with and without Budesonide on the development of BPD in ELBW infants.
研究概览
简要总结
A Pilot study to evaluate the safety and the efficacy of endotracheal instillation of pulmonary surfactant, with or without topical steroid (Budesonide), as a prophylactic treatment for Bronchopulmonary Dysplasia (a form of chronic lung disease) in extremely low birth weight infants. Cytokines (a group of inflammatory mediators) are measured in the tracheal aspirate before and after instillation of the study drugs.
详细描述
Bronchopulmonary Dysplasia (BPD) is still one of the most common complications of ventilated premature infants. Lung inflammation plays a major role in its pathogenesis. Systemic steroids can be given to control this inflammatory process but their widespread use is limited by their systemic side effects and concerns for long neurodevelopmental adverse sequelae. Delivering steroids by inhalation which has been proven to be effective in young infants with asthma has been shown to be unsatisfactory for ELBW infants with BPD. This may be due to the fact that current delivery devices do not meet the requirements of the specific anatomical and physiologic characteristics of the airways and breathing patterns in this special group of patients. A novel approach to facilitate delivery directly to the lungs, thereby avoiding systemic concerns has been demonstrated in a recent study in which budesonide ( a topical steroid) was given to ventilated preterm infants using surfactant as a vehicle.
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
- 24 Weeks 至 28 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight 501-1000 g and ≤ 28 weeks gestational age
- •Diagnosed as RDS requiring mechanical ventilation and surfactant therapy during the first 4 hours after birth
- •Still ventilated on day 5-9 of life.
- •An interval of at least 24 hours' duration between the last dose of indomethacin and the endotracheal instillation of study drug.
排除标准
- •Congenital or chromosomal anomalies
- •Occurrence of perinatal sepsis
- •Use of intravenous steroids > 7 days
研究组 & 干预措施
A (two study drugs group)
The standard management + two study drugs (endotracheal instillation of a mixture containing budesonide and Infasurf)
干预措施: Infasurf (Drug)
A (two study drugs group)
The standard management + two study drugs (endotracheal instillation of a mixture containing budesonide and Infasurf)
干预措施: Pulmicort (Drug)
B (one study drug group)
The standard management + one study drug (endotracheal instillation of Infasurf only).
干预措施: Infasurf (Drug)
C (no study drug group)
The standard management only.
干预措施: Sham (Other)
结局指标
主要结局
To measure the effect of surfactant with and without Budesonide on the development of BPD in ELBW infants.
时间窗: Supplemental oxygen requirement at 36 weeks' postmenstrual age (PMA)
The main goal of the study is to determine whether endotracheal instillation of surfactant (Infasurf) with or without potent topical steroid (Budesonide) reduces the development of Bronchopulmonary Dysplasia (BPD) in Extremely Low Birth Weight (ELBW) infants at high risk of BPD.
次要结局
- To measure the effect of surfactant with and without Budesonide on the inflammatory cytokines in tracheal aspirates.(The measurement of cytokines in tracheal aspirate samples will be done at the end of the study.)