A Multinational, Multicenter, Masked, Randomized, Controlled Study to Assess the Safety and Efficacy of Lucinactant for Inhalation Versus nCPAP Alone in Preterm Neonates 26 to 32 Weeks Gestational Age With RDS
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 6
- 主要终点
- Number of Participants With Respiratory Failure or Death
研究概览
简要总结
This study is to evaluate the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, in comparison to nCPAP alone, in preterm neonates with RDS, as assessed by the incidence of and time to respiratory failure and/or death due to RDS in the first 72 hours and 28 days of life. Half of the subjects will receive lucinactant for inhalation and half will receive standard of care (nCPAP alone).
详细描述
An unmet medical need exists for a means to deliver surfactant replacement therapy (SRT) to preterm neonates with RDS supported with nCPAP early in the course of the disease. This strategy has the potential to improve RDS prior to the development of respiratory failure, thereby avoiding the need for endotracheal intubation and mechanical ventilation (MV), or reduce the duration of MV, and the resultant potential for morbidity and complications. The ability to administer SRT via aerosol has the potential to address this unmet need.
Lucinactant for inhalation (AEROSURF) is an investigational drug-device combination product, designed to deliver aerosolized SRT to preterm neonates with RDS who are being supported with nCPAP. The drug component of lucinactant for inhalation is lyophilized lucinactant, a lyophilized form of SURFAXIN® (lucinactant) Intratracheal Suspension. The device component, the AEROSURF Delivery System (ADS), the next-generation device following use of the prototype device in earlier trials, uses novel technology to aerosolize lucinactant for inhalation.
This study evaluates the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, in comparison to nCPAP alone, in preterm neonates with RDS, as assessed by pre-specified outcome measures. In addition, this study will evaluate the device and the ability to administer up to 3 repeat doses.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The first 2 subjects at each site for each cohort will be dosed with open-label active treatment for training purposes. Following the first 2 subjects, preparation and delivery of treatment will be blinded from the study staff. Treatment will be delivered behind a partition and no information about treatment will be given to investigator, parents, or other applicable study staff.
入排标准
- 年龄范围
- 30 Minutes 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed ICF from legally authorized representative.
- •Gestational age: 26 to 32+6 weeks PMA.
- •Successful implementation of non-invasive support or ventilation within 30 minutes after birth.
- •Spontaneous breathing.
- •Investigator determination of RDS. A chest x-ray should be obtained before treatment to confirm the diagnosis.
- •Within the first 6 hours after birth, requires an nCPAP of 5 to 7 cm H2O that is clinically indicated for at least 15 minutes with an FiO2 > 0.25 to ≤ 0.35 to maintain SpO2 of 90% to 95%.
排除标准
- •A heart rate that cannot be stabilized above 100 bpm within 5 minutes of birth.
- •Recurrent episodes of apnea requiring positive pressure ventilation.
- •A 5 minute Apgar score <
- •Major congenital malformation(s) or craniofacial abnormalities that preclude the use of nCPAP.
- •Clinically significant diseases or conditions other than RDS which could potentially interfere with cardiopulmonary function.
- •A known or suspected chromosomal abnormality or syndrome.
- •Premature rupture of membranes > 3 weeks.
- •Hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis.
- •A need for intubation and/or invasive mechanical ventilation at any time before enrollment into the study.
- •The administration (or plan for administration) of another investigational agent or investigational medical device, any other surfactant agent, or systemic corticosteroids.
- •Presence of air leak on the baseline chest radiograph or diagnosed via ultrasound or illumination.
结局指标
主要结局
Number of Participants With Respiratory Failure or Death
时间窗: 28 days of life
Number of participants with respiratory failure due to RDS or death. Respiratory failure due to RDS is defined as intubation for mechanical ventilation and/or surfactant administration
次要结局
- Number With BPD(36 weeks post-menstrual age (PMA))
- Mortality(36 weeks PMA or 28 days of life (whichever is later))
- Number of Participants With Common Complications of Prematurity(36 weeks PMA)