A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Efficacy of SURFAXIN® (Lucinactant), in Very Low Birth Weight (VLBW) Infants at Risk for Developing Bronchopulmonary Dysplasia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Incidence of Death or Bronchopulmonary Dysplasia (BPD) at 36 Weeks
研究概览
简要总结
SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required continued intubation and received surfactants for the prevention or treatment of respiratory distress syndrome (RDS).
详细描述
Determine the safety and tolerability of SURFAXIN administration in the first weeks of life as a therapeutic approach for prevention of BPD. Determine whether treatment with SURFAXIN during the first two to three weeks of life can decrease the proportion of infants on mechanical ventilation or oxygen or the incidence of death or BPD in VLBW infants when assessed at 28 days of life and 36 weeks post-menstrual age (as determined by the need for supplemental oxygen).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Days 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature infants between 600 and 900 grams birth weight
- •Intubated and on mechanical ventilation
- •Sustained (>= 30 minutes) fraction of inspired oxygen (FiO₂) >= 0.30 within 8 hours prior to randomization
排除标准
- •Mother has prolonged rupture of membranes ≥ 2 weeks
- •Culture-proven sepsis
- •High grade intraventricular hemorrhage (IVH)
- •Congenital heart disease
- •Congential anomalies inconsistent with life or likely to confound efficacy or safety endpoints
- •FiO₂≥ 0.80 and mean airway pressure (MAP) ≥ 12 cmH2O at day of life (DOL) 3
- •FiO₂< 0.25 at any time between meeting the entry criteria to immediately prior to randomization
- •Concomitant use of any other surfactant within the first 48 hours of life
- •Prior use of nitric oxide
- •Prior use of steroids
- •Current participation in any other clinical trial or has received an experimental drug or used an experimental device
研究组 & 干预措施
SURFAXIN High Dose
SURFAXIN (lucinactant) at 175 mg/kg
干预措施: Lucinactant 175 mg/kg (Drug)
SURFAXIN Low Dose
SURFAXIN (lucinactant) at 90 mg/kg
干预措施: Lucinactant 90 mg/kg (Drug)
Placebo
Sham air using 3.0 mL/kg volume of air
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Death or Bronchopulmonary Dysplasia (BPD) at 36 Weeks
时间窗: 36 weeks post-menstrual age (PMA)
Number of participants who died or developed BPD, defined as oxygen requirement at 36 Weeks post-menstrual age
All-cause Mortality
时间窗: 36 weeks PMA
次要结局
- BPD at 28 Days(28 days of life)
- BPD at 36 Weeks(36 weeks PMA)
- Days Receiving Mechanical Ventilation (MV)(36 weeks PMA)
- Duration of Supplemental Oxygen(36 weeks PMA)
- Area Under the Curve for Fraction of Inspired Oxygen (FiO₂)(15 minutes prior to dose 1, 2 hours post dose 1, 6 hours post dose 1, 24 hours post dose 1, and daily from Study Day 2 to Study Day 25 and Day of Life 28)
- Area Under the Curve for Mean Arterial Pressure (MAP)(15 minutes prior to dose 1, 2 hours post dose 1, 6 hours post dose 1, 24 hours post dose 1, and daily from Study Day 2 to Study Day 25, and day of life 28)
- Incidence of Death or BPD at 28 Days(28 days of life)
- Days in Hospital(36 weeks PMA)