Impact of Erythropoietin in the management of Hypoxic Ischaemic Encephalopathy in resource-constrained settings: protocol for a randomized control trial

Beatrice Ezenwa,Iretiola Fajolu,Chinyere Ezeaka,Obiyo Nwaiwu,Omodele Olowoyeye,Gbenga Olorunfemi,Zainab Opoola,Anne Ogbenna

doi:10.1186/s12883-020-01751-y

Abstract

BackgroundPerinatal 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.MethodsThis 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.DiscussionPrevious 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.Trial registrationThe study has been registered with the Pan African Clinical trials registry on the 2nd of December 2018, with registration number PACTR201812814507775.

Highlights

Perinatal asphyxia (PA), 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 [1]
Hypoxic-Ischemic Encephalopathy is the commonest etiology for neonatal encephalopathies and accounts for 23% of all term newborn deaths worldwide [2]
Ekure et al [9] reported that HIE accounted for nearly 39% of perinatal mortalities at a tertiary hospital in Lagos, South-Western Nigeria

Summary

Introduction

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. Severe HIE occur in 0.1–0.3% of births in resource-rich countries [2, 3]. The incidence of HIE is greater in low and middle-income countries (LMICs) [4] occurring in nearly 35% of neonatal admissions in India while different hospital-based studies in Nigeria documented between 2.6 and 30% [5,6,7,8]. Ekure et al [9] reported that HIE accounted for nearly 39% of perinatal mortalities at a tertiary hospital in Lagos, South-Western Nigeria. The majority (about 90%) of cases of HIE that present to hospitals in Nigeria were moderate to severe [10]. The morbidity and mortality from HIE increases with increasing severity [10]

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