Impact of Erythropoietin in the management of Hypoxic Ischaemic Encephalopathy in resource-constrained settings: protocol for a randomized control trial
Open Access
- 4 May 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in BMC Neurology
- Vol. 20 (1), 1-8
- https://doi.org/10.1186/s12883-020-01751-y
Abstract
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.Funding Information
- University of Lagos Central Research Committee Grant (2019/05)
This publication has 47 references indexed in Scilit:
- Erythropoietin for Neuroprotection in Neonatal Encephalopathy: Safety and PharmacokineticsPEDIATRICS, 2012
- Effect of Hypothermia on Amplitude-Integrated Electroencephalogram in Infants With AsphyxiaPEDIATRICS, 2010
- The Malawi Developmental Assessment Tool (MDAT): The Creation, Validation, and Reliability of a Tool to Assess Child Development in Rural African SettingsPLoS Medicine, 2010
- Human Recombinant Erythropoietin in Asphyxia Neonatorum: Pilot TrialPEDIATRICS, 2010
- Moderate Hypothermia to Treat Perinatal Asphyxial EncephalopathyThe New England Journal of Medicine, 2009
- Erythropoietin Improved Neurologic Outcomes in Newborns With Hypoxic-Ischemic EncephalopathyPEDIATRICS, 2009
- Outcome after intrapartum hypoxic ischaemia at termSeminars in Fetal and Neonatal Medicine, 2007
- Neonatal Hypoxia/Ischemia Is Associated With Decreased Inflammatory Mediators After Erythropoietin AdministrationStroke, 2005
- New Avenues of Exploration for ErythropoietinJAMA, 2005
- Neurodevelopmental Outcome and Growth at 18 to 22 Months' Corrected Age in Extremely Low Birth Weight Infants Treated With Early Erythropoietin and IronPEDIATRICS, 2004