A DOUBLE BLIND, RANDOMIZED, CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF SYNTHETIC SURFACTANT (CHF 5633) IN COMPARISON TO PORCINE SURFACTANT (PORACTANT ALFA, CUROSURF®) IN THE TREATMENT OF PRETERM NEONATES WITH RESPIRATORY DISTRESS SYNDROME
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 23
- 主要终点
- Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio
研究概览
简要总结
A multicenter, double blind, randomized, single dose, active-controlled study to investigate the efficacy and safety of synthetic surfactant (CHF 5633) in comparison to porcine surfactant (Poractant alfa, Curosurf ®) in the treatment of preterm neonates with respiratory distress syndrome. Main objectives of this study are to investigate the short term efficacy profile of CHF 5633 vs. porcine surfactant (Poractant Alfa, Curosurf®) in terms of reduced oxygen requirement and ventilatory support and to evaluate the mid-term efficacy profile in terms of reduced incidence of bronchopulmonary dysplasia (BPD) and mortality/BPD rate at 36 weeks post menstrual age (PMA), mortality rate at 28 days and 36 weeks PMA, RDS-associated mortality through 14 days of age and other major co-morbidities of prematurity.
Inclusion criteria are: Written parental informed consent, inborn preterm neonates of either sex with a gestational age of 24+0 weeks up to 29+6 weeks, clinical course consistent with RDS, requirement of endotracheal surfactant administration within 24 hours from birth, fraction of inspired oxygen (FiO2) ≥0.30 for babies 24+0 to 26+6 weeks and FiO2 ≥0.35 for babies 27+0 to 29+6 weeks to maintain arterial oxygen saturation by pulse oximetry (SpO2) between 88-95%.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Hour 至 24 Hours（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 preterm neonates of either sex with a gestational age of 24+0 weeks up to 29+6 weeks
- •Clinical course consistent with RDS
- •Requirement of endotracheal surfactant administration within 24 hours from birth
- •Fraction of inspired oxygen (FiO2) ≥0.30 for babies 24+0 to 26+6 weeks and FiO2 ≥0.35 for babies 27+0 to 29+6 weeks to maintain SpO2 between 88-95%
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
- •Mothers with prolonged rupture of the membranes (>21 days duration)
- •Strong suspicion of congenital pneumonia/infection, sepsis
- •Presence of air leaks prior to study entry
- •Evidence of severe birth asphyxia
- •Neonatal seizures prior to study entry
- •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
CHF5633
Single dose within 24 hours from birth
干预措施: CHF5633 (Drug)
Poractant alfa
Single dose within 24 hours from birth
干预措施: Poractant alfa (Drug)
结局指标
主要结局
Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio
时间窗: Post-treatment Day 1: 30 min, at 1h, 3h, 6h, 12h, 18h, 24 h; Day 2, 3, 5, and 7
SpO2/FiO2 ratio The oxygen requirement and ventilatory support were assessed through arterial oxygen saturation, measured by pulse oximetry (SpO2 \[%\]) and ventilator settings, by measuring fraction of inspired oxygen (FiO2\[%\]) and SpO2/FiO2. Results are shown as change from baseline, summarized at post-treatment timepoints. Definitions: SpO2=Arterial Oxygen saturation by pulse oximetry; FiO2=Fraction of inspired oxygen; Baseline=The last pre-dose measurement taken on Day -1.
Fraction of Inspired Oxygen (FiO2) (Percent) During the First 24 h and up to Day 7
时间窗: Post-treatment Day 1: 30 min, at 1h, 3h, 6h, 12h, 18h, 24 h; Day 2, 3, 5, and 7
Fraction of inspired oxygen (FiO2) (percent) during the first 24 h and up to Day 7. Fraction of inspired oxygen (FiO2 \[percent\]). Results are shown as change from baseline, summarized at post-treatment time points. Definitions: FiO2=Fraction of inspired oxygen (percent); Baseline=The last pre-dose measurement taken on Day -1;
Number of Patients With Bronchopulmonary Dysplasia and Mortality
时间窗: 36 weeks post menstrual age, Day 14 Post-Natal Age, Day 28 Post-Natal Age
Bronchopulmonary dysplasia and mortality. Results summarize the following items: Number of patients who died and the number of patients who had bronchopulmonary dysplasia (BPD) were assessed by treatment, at 36 weeks post menstrual age (PMA). Number of patients who died by Day 28 post-natal age (PNA). Number of patients with respiratory distress syndrome (RDS)-associated mortality by Day 14 post-natal age (PNA). Definitions: BPD=Bronchopulmonary dysplasia; Mortality/BPD incidence=The incidence of neonates dead within 36-week PMA or alive at 36-week PMA with a diagnosis of BPD; PMA=Post menstrual age; PNA=Post-natal age; RDS=Respiratory distress syndrome;
次要结局
未报告次要终点