A Multicenter, Randomized, Controlled Trial Comparing the Safety and Effectiveness of Bronchoalveolar Lavage With Lucinactant to Standard Care for the Treatment of the Meconium Aspriation Syndrome (MAS) in Newborn Infants
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Number of Days Receiving Mechanical Ventilation (MV)
研究概览
简要总结
OBJECTIVES:
Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.
详细描述
PROTOCOL OUTLINE:
This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
Arm I: Patients receive lucinactant by bronchoalveolar lavage, into the right and left lung, followed by lung drainage. Treatment repeats when patient stabilizes or every 15 minutes for 2 courses.
Arm II: Patients receive standard treatment including oxygen, conventional mechanical ventilation, sedation, paralysis, vasopressors, and alkalinization.
Patients are followed for 12 months.
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 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of meconium aspiration syndrome (MAS)
- •Continuous mechanical ventilation (CMV) at time of entry
- •Enrollment within 48 hours of birth
- •Gestational age of ≥ 37 weeks
- •Oxygenation index of ≥ 5 and ≤ 30
- •Written informed consent signed and dated by the infant's parent(s) or legal guardian(s)
排除标准
- •Congenital anomalies likely to affect any primary or secondary endpoints
- •Uncontrollable air leaks
- •Hydrops fetalis
- •Rupture ≥ 3 weeks of the fetal membranes
- •Evidence of overwhelming bacterial infection at time of randomization
- •Markedly labile persistent pulmonary hypertension at time of randomization
- •Profound neurologic manifestations
- •Sustained postductal SpO₂of < 87% for ≥ 15 minutes at an FiO₂of 1.00
研究组 & 干预措施
Lucinactant
Lucinactant via bronchoaveolar lavage
干预措施: Lucinactant (Drug)
Standard Care
Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
干预措施: Standard Care (Other)
结局指标
主要结局
Number of Days Receiving Mechanical Ventilation (MV)
时间窗: 28 days
A patient is not receiving MV if he/she is removed from the mechanical ventilator for ≥ 24 hours. If a patient subsequently requires intubation and MV, the additional time will count as days receiving MV.
次要结局
- Incidence of Death(28 days)
- Number of Participants With Air Leaks(28 days)