A Randomized Trial: Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- ventilatory requirement
研究概览
简要总结
The purpose of this study is to determine whether the immediate bolus strategy combined with early nasal CPAP (nCPAP) treatment could decrease the subsequent need for ventilation compared to the administration of surfactant prophylaxis at 15 minutes after birth with early nCPAP in premature infants.
详细描述
Respiratory distress syndrome (RDS) is a syndrome in premature infants caused by developmental insufficiency of surfactant production and structural immaturity in the lungs. Exogenous surfactant therapy has become well established in newborn infants with RDS. Surfactant replacement therapy, either as a rescue treatment or a prophylactic, reduces mortality and several aspects of morbidity in babies with RDS. It is known that infants who are at a significant risk of RDS should receive prophylactic surfactant therapy, but the optimal timing and strategy for prophylactic surfactant therapy remains controversial. When administered immediately after delivery, surfactant mixes with the fetal lung fluid and reaches the alveoli before the onset of lung injury potentially created by the first applied positive pressure ventilation. As another approach, surfactant prophylaxis may be administered after resuscitation and stabilization.
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
- Single (Participant)
入排标准
- 年龄范围
- 1 Minute 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature infants born before 28 weeks' gestation
- •Premature infants born at 29 to 30 weeks' gestation who did not receive antenatal steroid were randomized before delivery
排除标准
- •Infants died at delivery room
研究组 & 干预措施
immediate bolus surfactant
干预措施: surfactant prophylaxis (Other)
post-resuscitation surfactant
干预措施: surfactant prophylaxis (Other)
结局指标
主要结局
ventilatory requirement
时间窗: within the first 5 days of life
Infants with RDS may require mechanical ventilation. Mechinal ventilation causes volu- and barotrauma in the lungs and associated morbidities. The earlier surfactant is given, the better it works. So immediate surfactant prophylaxis given before the first breath may decrease the requirement for mechanical ventilation compared with surfactant prophylaxis given at 15 minutes of age after resuscitation and stabilization.
次要结局
- bronchopulmonary dysplasia(first two months)
- duration of hospitalization(one year)
- mortality(one year)
- Pulmonary hemorrhage(first 72 hours of life)
- patent ductus arteriosus(first one week)
- retinopathy of prematurity(first two months)
- intraventricular hemorrhage(first one week)
- Pneumothorax(first 72 hours of life)
- necrotizing enterocolitis(first one month)