Early Bolus Surfactant Replacement Therapy Versus Standard Care in Term (>=37 Weeks) Neonates With Actant Replacement Therapy Versus Standard Care in Term Neonates With Meconium Aspiration Syndrome: An Open Label Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Duration of Total respiratory support
研究概览
简要总结
The objective of the study is to compare the total duration of respiratory support in term neonates (≥37weeks) with meconium aspiration syndrome, who are provided early(≤2hr) bolus surfactant therapy versus standard care.
详细描述
Enrolled participants will be randomly assigned to one of two study groups: 1. early(≤2hr) bolus surfactant replacement therapy or 2. standard care
Intervention group: The neonates enrolled in this group will receive early bolus surfactant replacement therapy within 2hr of life.
Control group: The neonates enrolled in this group will receive standard care according to standard unit protocol
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Minutes 至 2 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestation age ≥ 37 week
- •Cephalic presentation
- •Singleton pregnancy
- •Age < 2 hours
- •Baby delivered through meconium stained amniotic fluid
- •Presence of respiratory distress (DOWNE's score ≥4)
排除标准
- •Major congenital malformation
- •Antenatal diagnosed CHD
- •Hydrops fetalis
- •Air leaks before enrolment
研究组 & 干预措施
Early bolus surfactant replacement therapy
Neonates randomized to this group will receive early bolus surfactant replacement therapy within 2hr of life
干预措施: Bovine surfactant (Drug)
结局指标
主要结局
Duration of Total respiratory support
时间窗: Birth to 28 days
Combined duration of invasive + non invasive ventilation
次要结局
- Proportion of neonates requiring mechanical ventilation(Birth to 28 days)
- Severity of respiratory distress(Birth to 28 days)
- Proportion of neonates requiring Non Invasive Ventilation(Birth to 28 days)
- Duration of oxygen therapy(Birth to 28 days)
- Mortality(Birth to 28 days)
- Complications(Birth to 28 days)
- Duration of hospital stay(Birth to 28 days)
- Duration of Mechanical Ventilation(Birth to 28 days)
研究者
Sushma Nangia, M.D.
Dr. Sushma Nangia, Director Professor & Head, Neonatology
Lady Hardinge Medical College