ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant Therapy) Versus InSurE (Intubate, Surfactant, Extubate) in Preterm Infants With Respiratory Distress Syndrome (RDS): Prospective Randomised Control Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Incidence of early ventilation hours
研究概览
简要总结
Minimally invasive surfactant therapy via a small vascular catheter - ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant Therapy) versus InSurE (Intubate, Surfactant Extubate) in preterm infants with Respiratory Distress Syndrome (RDS): A prospective randomized clinical trial.
详细描述
After meeting all the inclusion criteria, eligible infants will be randomized to receive surfactant either through the ECALMIST or the InSurE methods. The attending neonatologist or neonatal team will have full discretion to decide when to intubate and when to extubate or wean the infant off the ventilator or NCPAP.
General guidelines for reintubation include persistent pH<7.20, PaCO2 > 65 mmHg, very frequent apnea (>2-3/hour of apneic or bradycardic spells not responsive to corrective therapy), frequent desaturations >3/hour not responding to increase in FiO2 or increase in FiO2 to 100%), or apneas requiring prolonged PPV. For the purpose of the study a successful outcome for the primary objective will have occurred if the infant has not been reintubated and ventilated during the initial 3 days of life.
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
- 24 Weeks 至 31 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All should apply:
- •Newborn less than 32 weeks gestation at birth
- •Postnatal age < 24 hrs of life
- •Clinical diagnosis of RDS
- •Spontaneously breathing on NCPAP
- •Clinical decision to give surfactant.
排除标准
- •Lack of parental consent.
- •Need for mechanical ventilation
- •Major congenital malformation
结局指标
主要结局
Incidence of early ventilation hours
时间窗: 3 days
The number of the newborn infants needed ventilation in the 1st 3 days of life
次要结局
- Apnea(15 minutes)
- Desaturation(15 minutes)
- Bradycardia(15 minutes)
- Total ventilation hours(hospital admition days)
- Early ventilation hours(3 days)
- Incidence of Chronic lung disease(1st 2 months of life)
研究者
Yahya Al Ethawi
Dr
University of Manitoba