Non Inferiority Trial Investigating Surfactants Administered Via MIST
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- Number of infants requiring Endotracheal Intubation
研究概览
简要总结
RESEARCH DESIGN Multicenter, randomized, controlled trial. RECRUITMENT Entry criteria Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome. Infants who are on NCPAP and FiO2 ≥0.30 will randomized to curosurf or infasurf via MIST.
Exclusion criteria Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress.
Babies who require emergent intubation will not be enrolled in the interventions.
Parental Consent will be obtained prior to randomization.
详细描述
INTERVENTION Infants who on CPAP who reach the threshold of 30% oxygen will be randomized to calfactant (Infasurf), 3ml/kg or poractant alfa (Curosurf), 2.5ml/kg, administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA).
A second dose of calfactant (Infasurf) 3ml/kg or poractant alfa (Curosurf), 1.25ml/kg, will be administered via MIST their fiO2 reaches the threshold of 30% between 6 and 48 hours after the first dose.
No further surfactant should be given in the first 7 days unless the infant reaches the intubation criteria.
POST-INTERVENTION MANAGEMENT Other than the requirement to adhere to intubation criteria in the first week, and in some cases perform a room air trial at 36 weeks corrected gestation, management will be at the discretion of the clinical team.
Titration of CPAP pressure is encouraged, with a permitted maximum of 8 cm H2O. Use of nasal IPPV is allowable for apnea, but discouraged for RDS and should only be after at least one dose of surfactant has been given. Early caffeine therapy is expected.
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, Investigator)
盲法说明
Surfactant will be sent from Investigational Pharmacy
入排标准
- 年龄范围
- — 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome confirmed by a chest x-ray on nasal continuous positive airway pressure (NCPAP) and FiO2 ≥0.30
排除标准
- •Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress.
- •Infants who require emergent intubation will not be enrolled in the interventions.
研究组 & 干预措施
Calfactant (Infasurf)
Neonate, 28-35 weeks gestation, less than 48 hours of age, with respiratory distress syndrome on CPAP > 30% oxygen will be given 3ml/kg of Calfacant
干预措施: MIST surfactant (Drug)
Poractant alfa (Curosurf)
Neonate, 28-35 weeks gestation, less than 48 hours of age, with respiratory distress syndrome on CPAP > 30% oxygen will be given 2.5ml/kg of Poractant alfa.
干预措施: MIST surfactant (Drug)
结局指标
主要结局
Number of infants requiring Endotracheal Intubation
时间窗: 7 days
Infants will have an endotracheal placed if their inspired oxygen is \>45% for more than 15 minutes
次要结局
- Duration of positive pressure support(36 weeks corrected gestational age)
- Duration of Supplemental oxygen(36 weeks corrected gestational age)
研究者
Matthew Derrick
Attending Neonatologist
Endeavor Health