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

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

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 co...

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Bibliographic Details
Published in:BMC neurology Vol. 20; no. 1; p. 171
Main Authors: Ezenwa, Beatrice, Ezeaka, Chinyere, Fajolu, Iretiola, Ogbenna, Anne, Olowoyeye, Omodele, Nwaiwu, Obiyo, Opoola, Zainab, Olorunfemi, Gbenga
Format: Journal Article
Language:English
Published: England BioMed Central Ltd 04-05-2020
BioMed Central
BMC
Subjects:
Asphyxia
Asphyxia neonatorum
Babies
Biomarkers
Blood flow
Blood pressure
Brain damage
Brain injuries
Brain injury
Cerebral blood flow
Clinical trials
Comparative analysis
Drug dosages
Electrolytes
Encephalopathy
EPO and neurodevelopment
Erythropoietin
Gestation
Hypothermia
Hypoxemia
Hypoxia
Hypoxic-ischemic encephalopathy
Infants
Ischemia
Mortality
Neonates
Neuroprotection
Newborn babies
Newborn infants
Perinatal asphyxia
Software industry
Studies
Study Protocol
Teaching hospitals
Traumatic brain injury
Nigeria
United States
Perinatal asphyxia
EPO and neurodevelopment
Hypoxic-ischemic encephalopathy
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Summary: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.
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ISSN:1471-2377
1471-2377
DOI:10.1186/s12883-020-01751-y