Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in stroke tissue loss
研究概览
简要总结
The aim of the study is to perform a randomized double-blind placebo controlled prospective study in newborn infants with MRI confirmed Middle Cerebral Artery (MCA) Perinatal Arterial Ischemic Stroke (PAIS) with darbepoetin. It will be investigated whether intravenous administered darbepoetin can induce the formation of neuronal tissue and restore brain function in neonates who suffered from PAIS compared to placebo treated controls. The ultimate goal of this study is therefore to develop a therapy using erythropoiesis-stimulating agents (ESA) such as darbepoetin to reduce or even prevent lifelong consequences of PAIS-related brain injury in this group of term newborns.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This will be a double-blinded study, meaning that both the patient (and his/her parents) and the health care providers, including neonatologist, pediatrician, nurses, physiotherapists, etc, are not allowed to know what treatment the patient has been given. Those that collect outcome parameters, such as MRI data and neurodevelopmental outcome, are also unaware of treatment allocation, meaning that blinding will be maintained during the full study-period of 18 months.
入排标准
- 年龄范围
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns ≥ 36+0 weeks of gestation, both male and female
- •MRI confirmed diagnosis of acute PAIS, in the MCA region with involvement of the cortical spinal tract (e.g. Posterior Limb of Internal Capsule [PLIC] or peduncles) within one week after birth
- •Written informed consent from custodial parent(s)
排除标准
- •Moderate -severe Hypoxic-Ischemic Encephalopathy (HIE) with or without hypothermia therapy
- •Any proven or suspected major congenital anomaly, chromosomal disorder, metabolic disorder;
- •Presence of a serious infection of the central nervous system;
- •No realistic prospect of survival, (e.g. severe brain injury), at the discretion of the attending physician.
- •Infant for whom withdrawal of supportive care is being considered.
研究组 & 干预措施
Darbepoetin
Darbepoetin alfa (Aranesp, Amgen)
干预措施: Darbepoetin Alfa (Drug)
Placebo
Saline
干预措施: Saline (Drug)
结局指标
主要结局
Change in stroke tissue loss
时间窗: 6-8 weeks of age
The primary objective is to determine whether there is a difference in the degree in stroke tissue loss between darbepoetin and placebo treatment, which will be measured by the change in lesion size between the time of onset of the insult and 6-8 weeks of age. The primary endpoint will be estimated using advanced volumetric magnetic resonance (MRI) techniques, performed within one week after clinical presentation and at 6-8 weeks of age.
次要结局
- Neurodevelopment(18 months of age)
- Neurological assessment(18 months of age)
- Reorganization of corticospinal connectivity(6-8 weeks of age)
- Development of Cerebral Palsy(18 months of age)
研究者
dr. M.J.N.L. Benders
Principal Investigator UMC Utrecht
UMC Utrecht