Advancing IL-1Ra to Prevent Inflammatory Disease in Preterm Infants - Pilot
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of participants with treatment-related serious adverse reactions (suspected and unexpected)
研究概览
简要总结
Phase I/II study of anakinra to prevent the impact of perinatal inflammation in extremely premature infants.
详细描述
With improvements in antenatal and neonatal care over the last 20 years, now infants are born as early as 22 weeks gestation and survive to discharge from hospital. This increased survival comes with increased risk of long term issues such as cerebral palsy and chronic lung disease. There is strong evidence to show these risks are increased due to an underlying inflammatory process initiated around the time of premature birth. This study aims to prove the safety of treating infants born between 24-27+6 weeks gestation with Anakinra, a medication which is similar to an anti-inflammatory molecule the body makes itself called Interleukin 1 Receptor Antagonist (IL-1Ra). Anakinra acts to reduce the inflammatory response and is currently used in adults and children as young as 8 months to manage autoimmune inflammatory conditions. This study looks at the safety of giving Anakinra to babies born extremely premature, over the first 3 weeks of life. Once safety is established, the investigators will conduct a larger trial studying the efficacy of this treatment for reducing the risk of long-term complications caused by neonatal inflammation in extremely preterm infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 24 Weeks 至 28 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born at 24 to 27+6 weeks gestation
排除标准
- •Inability of the legal representatives to consent
- •Any disease or condition that the investigators judge could confound the trial results; these include, but are not limited to, genetic syndromes, severe cardiac abnormalities, substantial pre-/perinatal compromise (profound/severe hypoxia (SaO2 <80% for >3h), congenital diaphragmatic hernia, intrauterine stroke and others.
- •Imminent death
研究组 & 干预措施
Anakinra
First 6 enrolled infants given 1.0mg/kg anakinra alternate daily IV for first 3 weeks of life.
Remaining 18 enrolled infants given 0.8mg/kg anakinra daily IV for the first 3 weeks of life, if infant is ≥ 26 weeks gestation.
If infant is < 26 weeks gestation, dosing of 1.0mg/kg anakinra alternate daily IV for the first 3 weeks of life, will continue (3 infants only).
干预措施: Anakinra (Drug)
结局指标
主要结局
Number of participants with treatment-related serious adverse reactions (suspected and unexpected)
时间窗: 3 weeks
Monitoring of vital signs and documentation of any significant adverse effects, for the duration of treatment which is 3 weeks, such as cardiorespiratory deterioration requiring escalation of therapy (need to start or increase inotropic medication), need for cardiopulmonary resuscitation, incidence of sepsis and death within 15mins of infusion. Continuously collected physiological data will be summarised as area under the curve in 24h epochs. Serum creatinine will be monitored for incidence of acute kidney injury on days 3, 7 and 14. Liver function will be monitored for incidence of drug-induced liver injury on days 3, 7 and 14.
次要结局
- Plasma interleukin-1 receptor antagonist levels will be measured and reported in pg/mL for each participant conferred by treatment with anakinra(22 days)