A Multicenter, Randomized, Open-Label, Controlled Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Preterm Neonates 29 to 34 Weeks PMA: Dose Escalation and Study Extension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 11
- 主要终点
- Peri-Dosing Events
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of aerosolized surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses to preterm neonates 29 to 34 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS), compared to neonates receiving nCPAP alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 29 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent from a legally authorized representative
- •Gestational age 29 to 34 completed weeks (34 weeks 6 days) post menstrual age (PMA)
- •Successful implementation of controlled nCPAP within 90 minutes after birth
- •Spontaneous breathing
- •Chest radiograph consistent with RDS
- •Need for moderate levels of supplemental oxygen and nCPAP to maintain oxygen saturation of 88% to 95% for at least 30 minutes within the first 21 hours after birth
排除标准
- •Heart rate that cannot be stabilized above 100 beats/minute within 5 minutes of birth
- •Recurrent episodes of apnea occurring after the initial newborn resuscitation period (ie, 10 minutes after birth) requiring intermittent positive pressure breaths using inflating pressures above the set CPAP pressure administered manually or mechanically through any patient interface
- •A 5 minute Apgar score < 5
- •Major congenital malformation(s) and cranial/facial abnormalities that preclude nCPAP, diagnosed antenatally or immediately after birth
- •Other diseases or conditions potentially interfering with cardiopulmonary function (eg, hydrops fetalis or congenital infection such as TORCH)
- •Known or suspected chromosomal abnormality or syndrome
- •Prolong rupture of membranes (PROM) > 2 weeks
- •Evidence of hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis
- •Need for endotracheal intubation and mechanical ventilation
- •Has been administered: another investigational agent or exposure to an investigational medical device, any other surfactant agent, steroid treatment after birth
研究组 & 干预措施
nCPAP alone
nCPAP therapy alone
干预措施: nCPAP alone (Device)
Aerosolized lucinactant (25 mg/kg)
25 mg total phospholipids (TPL)/kg: Lucinactant for inhalation with nCPAP
干预措施: Lucinactant for Inhalation (Drug)
Aerosolized lucinactant (50 mg/kg)
50 mg TPL/kg: Lucinactant for inhalation with nCPAP
干预措施: Lucinactant for Inhalation (Drug)
Aerosolized lucinactant (75 mg/kg)
75 mg TPL/kg: Lucinactant for inhalation with nCPAP
干预措施: Lucinactant for Inhalation (Drug)
Aerosolized lucinactant (100 mg/kg)
100 mg TPL/kg: Lucinactant for inhalation with nCPAP; repeat dosing possible if criteria met.
干预措施: Lucinactant for Inhalation (Drug)
Aerosolized lucinactant (150 mg/kg)
150 mg TPL/kg: Lucinactant for inhalation with nCPAP; repeat dosing possible if criteria met.
干预措施: Lucinactant for Inhalation (Drug)
结局指标
主要结局
Peri-Dosing Events
时间窗: Within 48 Hours after Initiation of Study Treatment
Pre-specified adverse events that occured during treatment administration; does not include nCPAP alone
All Cause Mortality
时间窗: Within 36 Weeks PMA
Serum Electrolytes
时间窗: 24 Hours Post Randomization
Oxygen Saturation Levels
时间窗: Within 3 Hours of Randomization
Oxygen saturation as determined by pulse oximetry
次要结局
- PCO2(Within 3 Hours of Randomization)