EUCTR2016-001974-14-Outside-EU/EEA进行中（未招募）1 期
An Open-Label, Multicenter, Randomized, Controlled Study in Spontaneously Breathing Preterm Neonates with Respiratory Distress Syndrome to Compare Two Procedures for Porcine Surfactant (poractant alfa, Curosurf®) Administration: a Less Invasive Method (LISA) During Non-Invasive Ventilation (NIV) and the Conventional Administration During Brief Invasive Ventilation. - LISPAP (Less Invasive Surfactant administration combined with nCPAP)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Subjects must meet all the following inclusion criteria to be eligible for enrollment into the study:
- •1. Written informed consent obtained by parents/legal representative (according to local regulation) prior to or after birth;
- •2. Preterm neonates of either sex aged =30 minutes and <24 hours, spontaneously breathing and stabilized on NIV;
- •3. Gestational age of 25+0 weeks up to 28+6 completed weeks; enrollment will be restricted to subjects aged 27+0 weeks up to 28+6 GA weeks until safety evaluation of first 15 subjects is completed;
- •4. Clinical course consistent with RDS;
- •5. FiO2 =0.30 to maintain preductal SpO2 in the target range of 88–95%.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 150
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The presence of any of the following will exclude a subject from the study enrollment:
- •1. Need for immediate endotracheal intubation for cardiopulmonary resuscitation or insufficient respiratory drive;
- •2. Use of nasal high frequency oscillatory ventilation (nHFOV) prior to study entry;
- •3. Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide);
- •4. Known genetic or chromosomal disorders, major congenital anomalies (congenital heart diseases, myelomeningocele, etc);
- •5. Mothers with prolonged premature rupture of the membranes (>21 days duration) which could cause complications (in particular severe pulmonary hypoplasia due to oligohydramnios);
- •6. Presence of air leaks if identified and known prior to study entry;
- •7. Evidence of severe birth asphyxia (e.g. continued need for resuscitation at 10 minutes after birth, altered neurological state or neonatal encephalopathy);
- •8. Neonatal seizures prior to study entry;
- •9. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk;
- •10. Participation in another clinical trial of any medicinal product, placebo, experimental medical device or biological substance conducted under the provisions of a protocol on the same therapeutic target; the participation in studies involving diagnostic devices or studies with treatments for different conditions than lung and respiratory function impairments may be permitted following an agreement with the sponsor. Non-interventional observational studies are allowed.
研究者
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