Neonatology unit, Department of Paediatrics, College of Medicine University of Lagos, Lagos, Nigeria.
Department of Paediatrics, Lagos University Teaching Hospital, Lagos, Nigeria.
BMC Neurol. 2020 May 4;20(1):171. doi: 10.1186/s12883-020-01751-y.
Perinatal asphyxia, more appropriately known as hypoxic-ischemic encephalopathy (HIE), is a condition characterized by clinical and laboratory evidence of acute or sub-acute brain injury resulting from systemic hypoxemia and/or reduced cerebral blood flow. HIE is a common and devastating clinical condition in resource-poor countries with poor treatment outcome. This paper describes the protocol for an ongoing study that aims to evaluate the neuroprotective effects of Erythropoietin (EPO) as compared to routine care in the management of moderate to severe HIE among term infants.
This study is a double-blind randomized controlled trial that will be conducted in the neonatal wards of the Lagos University Teaching Hospital (LUTH), Lagos, Nigeria, over a two-year period after ethical approvals and consents. One hundred and twenty-eight term newborns (≥ 37 weeks gestation) diagnosed with moderate/ severe HIE at admission will be allocated by randomization to receive either EPO or normal saline. All the participants will be offered standard care according to the unit protocol for HIE. Baseline investigations and close monitoring of the babies are done until discharge. Participants are followed up for 2 years to monitor their outcome (death or neurological development) using standard instruments.
Previous trials had shown that EPO confers neuroprotective benefits and improve neurological and behavioral outcome in infants with HIE both singly or as an adjuvant to therapeutic hypothermia. This study hypothesized that administering EPO to newborns with moderate /severe HIE can positively influence their clinical and neurological outcomes and will provide evidence to either support or disprove the usefulness of Erythropoietin as a sole agent in the treatment of HIE, especially in resource-limited environment with the highest burden of the disease.
The study has been registered with the Pan African Clinical trials registry on the 2nd of December 2018, with registration number PACTR201812814507775.
围产期窒息，更恰当地称为缺氧缺血性脑病（HIE），是一种以临床和实验室证据为特征的疾病，表明急性或亚急性脑损伤是由全身低氧血症和/或脑血流减少引起的。HIE 在资源匮乏的国家是一种常见且破坏性极大的临床疾病，其治疗效果不佳。本文介绍了一项正在进行的研究方案，该研究旨在评估促红细胞生成素（EPO）与常规治疗相比在治疗足月婴儿中至重度 HIE 中的神经保护作用。
这项研究是一项双盲随机对照试验，将在获得伦理批准和同意后，在尼日利亚拉各斯大学教学医院（LUTH）的新生儿病房进行，为期两年。128 名入院时诊断为中度/重度 HIE 的足月新生儿（≥37 周妊娠）将通过随机分配接受 EPO 或生理盐水。所有参与者将根据 HIE 单元方案接受标准护理。在出院前进行基线调查和密切监测婴儿。使用标准仪器对参与者进行为期 2 年的随访，以监测其结局（死亡或神经发育）。
先前的试验表明，EPO 可提供神经保护作用，并改善 HIE 婴儿的神经和行为结局，无论是单独使用还是作为治疗性低温的辅助治疗。这项研究假设，给患有中/重度 HIE 的新生儿施用 EPO 可以对其临床和神经结局产生积极影响，并提供支持或反驳 EPO 作为治疗 HIE 的单一药物的有用性的证据，特别是在资源有限且疾病负担最高的环境中。
该研究已于 2018 年 12 月 2 日在泛非临床试验注册中心注册，注册号为 PACTR201812814507775。
