A Randomized, Open, Multinational, Multicentre,2-Part Study In Spontaneously Breathing Preterm Neonates With Mild To Moderate Respiratory Distress Syndrome (RDS) To Investigate The Safety, Tolerability And Efficacy Of Inhaled Nebulised Poractant Alfa (Porcine Surfactant, Curosurf®) In Comparison With Nasal Continuous Positive Airway Pressure (nCPAP) Alone
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
The present study will mainly aim at investigating the safety, tolerability and efficacy of different escalating single doses administration of nebulised Curosurf®, in preterm neonates with RDS (Respiratory Distress Syndrome) during nCPAP.
详细描述
The study will be conducted in spontaneously breathing preterm neonates with mild to moderate RDS and will consist of two parts:
Part I, with the objective to assess the safety and tolerability of single ascending doses of nebulised Curosurf® ; Part II, with the objective to compare the efficacy of nebulised Curosurf®, administered at two selected doses from part I, during nCPAP, versus nCPAP alone in terms of incidence of respiratory failure in the first 72 hours of life.
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
- 28 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained by parents/legal representative (according to local regulation) prior to or after birth
- •Inborn neonates from 28+0 to 32+6 weeks of gestational age (GA), spontaneously breathing and stabilised on nCPAP
- •Clinical course consistent with RDS.
- •Receiving CPAP pressure 5-8 centimeter of water (cm H2O) and fraction of inspired oxygen (FiO2) between 0.25 and 0.40 to maintain saturation of peripheral oxygen (SpO2) between 88% and 95% for at least 30 minutes. Randomization should occur between 60 minutes and 12 hours after birth.
排除标准
- •Early need for endotracheal intubation for cardiopulmonary resuscitation in delivery room or within 1 hour from birth because of severe RDS
- •Respiratory Distress not secondary to surfactant deficiency
- •Use of surfactant prior to study entry and need for endotracheal administration of any other treatment.
- •Major congenital anomalies.
- •Evidence of severe birth asphyxia
- •Mothers with prolonged rupture of the membranes
- •Presence of air leaks.
- •Presence of IVH (intraventricular hemorrhage ) ≥ III.
- •Hypotension or evidence of hemodynamic instability.
- •Any condition that, in the opinion of the Investigator, would place the neonate at undue risk.
- •Participation in another clinical trial
研究组 & 干预措施
nCPAP+ Nebulised Curosurf®
Curosurf® administered through nebulization
干预措施: nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part I) (Drug)
nCPAP+ Nebulised Curosurf®
Curosurf® administered through nebulization
干预措施: nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part II) (Drug)
nCPAP alone (control)
Standard of care, respiratory support used also during experimental arms
干预措施: nCPAP (nasal Continuous Positive Airway Pressure) alone (Part I) (Other)
nCPAP alone (control)
Standard of care, respiratory support used also during experimental arms
干预措施: nCPAP (nasal Continuous Positive Airway Pressure) alone (Part II) (Other)
结局指标
主要结局
Adverse Events
时间窗: discharge or 36 weeks post menstrual age (PMA), whichever comes first
Any untoward medical occurrence in a clinical trial neonate administered a medicinal product and which does not necessarily have a casual relationship with the treatment
Adverse Drug Reactions
时间窗: discharge or 36 weeks post menstrual age (PMA), whichever comes first
Any untoward and unintended responses to an investigational product related to any dose administered
Percentage of neonates with respiratory failure
时间窗: in the first 72 hours of life
Respiratory failure defined as: need for endotracheal surfactant administration and/or mechanical ventilation
次要结局
未报告次要终点