Prophylactic Minimally Invasive Surfactant Evaluation
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Endotracheal Intubation
研究概览
简要总结
The purpose of this study is to explore the question: Does prophylactic administration of exogenous surfactant in the delivery room, using a minimally-invasive technique, improve outcome in preterm infants 22-29 weeks' gestation compared to rescue treatment using the same technique?
详细描述
RESEARCH DESIGN Multicenter, randomized, controlled trial.
Northshore Evanston Hospital will be the primary site. It is hoped that Northwest Community, University of Chicago, Edwards Hospital, Advocate Park Ridge, Advocate Oak Lawn and Advocate Illinois Masonic will also join the study.
RECRUITMENT Entry criteria Inborn preterm infants 22 0/7-29 6/7 weeks' gestation, with be randomized to prophylactic Minimally Invasive Surfactant Therapy (MIST) in the delivery room compared to rescue MIST if fraction of inspired oxygen (FiO2) ≥0.30 at less than 48 hours of age. Babies in both groups will be managed on nasal continuous positive airway pressure (NCPAP) pressures of 5-8 cm water.
Exclusion criteria Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress.
Babies who require emergent intubation in the delivery room will not be enrolled in the interventions.
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
- — 至 15 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational age <30 weeks
- •Antenatal consent from Parent
排除标准
- •Congenital anomalies
- •Alternate cause of respiratory distress
研究组 & 干预措施
Prophylactic Surfactant via Minimally Invasive Technique
Infants randomized to prophylactic surfactant treatment will receive a dose of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA), at a dosage of 200 mg/kg as soon as possible after delivery (within 15 minutes).
干预措施: Poractant Alfa (Drug)
Rescue Surfactant via Minimally Invasive Technique
The control group will be given surfactant will receive a dose of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA), at a dosage of 200 mg/kg if their fiO2 reaches a threshold of ≥30% within the first 48 hours of life.
干预措施: Poractant Alfa (Drug)
结局指标
主要结局
Endotracheal Intubation
时间窗: 7 days
Oxygen requirement \> 45% requiring endotracheal intubation
次要结局
- Bronchopulmonary dysplasia(36 weeks corrected gestational age)
研究者
Matthew Derrick
Attending Neonatologist
Endeavor Health