NCT01651637已完成1 期
A First in Human Clinical Study on the Safety and Tolerability of Two Escalating Single Doses of CHF 5633 (Synthetic Surfactant) in Preterm Neonates With Respiratory Distress Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Monitoring of adverse events following CHF5633 administration
研究概览
简要总结
The aim of this study is to investigate the safety and tolerability of intratracheal administration of two different single doses of CHF 5633 in preterm neonates with RDS in terms of adverse events, adverse drug reactions, hematology and biochemistry values, the incidence of major neonatal morbidities including bronchopulmonary dysplasia (BPD) and mortality.
详细描述
The study will be a multicentre, open-label, single escalating dose, per-cohort design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 27 Weeks 至 34 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 any study-related procedures
- •Inborn and outborn, preterm neonates of either sex with a gestational age of 27 weeks up to 33 weeks+6
- •Clinical and radiological findings typical of RDS
- •Age on admission to the study < 24 hours from birth
- •Requirement of endotracheal intubation for surfactant administration
- •Fraction of inspired oxygen (FiO2) > 0.35 to maintain SpO2 between 90-95 %
- •Documentation of normal cranial ultrasound scan
排除标准
- •Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide)
- •Known genetic or chromosomal disorders, major congenital anomalies (cardiac malformations, myelomeningocele etc)
- •Maternal drug abuse (heroin, methadone, methamphetamine, or cocaine) or significant alcohol consumption during pregnancy
- •Clinical chorioamnionitis (Appendix III)
- •Strong suspicion of congenital pneumonia/infection, sepsis
- •Evidence of severe birth asphyxia or a 5 minutes Apgar score less / equal 3
- •Presence of air leaks prior to study entry
- •Neonatal seizures prior to study entry
- •Mothers with prolonged rupture of the membranes (> 3 weeks duration)
- •Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
- •Participation in another clinical trial of any placebo, drug or biological substance conducted under the provisions of a protocol
研究组 & 干预措施
Synthetic Surfactant
Experimental
Cohort Design
干预措施: synthetic surfactant (CHF5633) (Drug)
结局指标
主要结局
Monitoring of adverse events following CHF5633 administration
时间窗: For duration of hospital stay (expected average of 9 weeks)
次要结局
- CHF 5633 efficacy profile (oxygenation , ventilatory requirements and need for rescue surfactant treatment),systemic absorption and immunogenicity assesment(At min 30, at hrs 1, 3, 6, 12, 24, at days 2, 3, 7 and at days 10, 28, at 36 weeks pma post dosing for ventilatory requirements, at pre-dose and 3 hrs and 24 hrs post dosing for systemic absorption and at 8 wks after administration for immunogenicity)
研究者
研究点 (1)
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