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Public title |
10/12/2018 |
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ERYTHROPOIETIN AND MAGNESIUM SULPHATE IN HYPOXIC ISCHAEMIC ENCEPHALOPATHY |
Erythropoietin and Magnesium Sulphate in Hypoxic Ischaemic Encelpalopathy |
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10/12/2018 |
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THE ROLE OF ERYTHROPOIETIN AND MAGNESIUM SULPHATE IN HYPOXIC ISCHAEMIC ENCEPHALOPATHY: HOPE FOR THE PERINATALLY ASPHYXIATED |
The Role of Erythropoietin and Magnesium Sulphate in Hypoxic Ischaemic Encephalopathy: Hope for the Perinatally Asphyxiated |
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10/12/2018 |
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Perinatal asphyxia, more appropriately known as hypoxic-ischemic encephalopathy (HIE), is a clinical condition characterized by clinical and laboratory evidence of acute or subacute brain injury resulting from systemic hypoxemia and/or reduced cerebral blood flow in the newborn. It is the commonest etiology for neonatal encephalopathies and accounts for 23% of all term newborn deaths worldwide. While the incidence of severe perinatal asphyxia in resource-rich countries is about 0.1-0.3% of total births, some hospital based studies in Nigeria documented between 3.2% and 30% prevalence and it accounts for between 45% and 83% of perinatal mortalities in some Nigerian studies. Survivors of severe HIE are also at high risk of developing severe cognitive and/or motor impairment, seizure disorders, deafness, and vision loss. Therapeutic hypothermia is currently the gold standard for treating HIE. Other new interventions include high dose Erythropoietin (EPO) and Magnesium sulfate (MgSO4).
EPO is a drug widely known in NICUs for the management of Anemia of prematurity. It has been found to also be a neuroprotective agent, with remarkable neuroprotective and neuro-regenerative effects. Its neuroprotective effects are especially prominent in damages related to ischemia-reperfusion injuries. The neuroprotective properties of Magnesium have also been demonstrated in several animal studies. Magnesium has beneficial effect in cerebral palsy reduction in preterm infants of mothers that received prenatal Magnesium sulfate.
Given the level of poverty in our environment it is most reasonable to attempt to address issues of morbidities more proactively by targeting evidence based cost effective measures that will not only curtail mortality but will also enhance quality of life of survivors of PA. The present study aims to evaluate the neuro protective effects of EPO and MgSO4 in the management of severe PA in term infants at Lagos University Teaching Hospital, Lagos.
All term newborns (≥ 37 weeks gestation) diagnosed of perinatal asphyxia at admission and who are <72 hours of age will be recruited and randomized into two groups. Group A will receive high dose Erythropoietin, Group B will receive standard dose of MgSO4 while Group C will not receive any of the drugs but will receive intravenous normal saline as a placebo. All the participants will be offered standard care according to the unit protocol for perinatal asphyxia. Clinical course and baseline characteristics will be recorded on a pre-designed proforma. All participants will undergo a cranial ultrasound scanning, MRI studies and EEG monitoring looking for abnormalities characteristic of HIE. Outcome measures include death or neurodevelopmental impairment at discharge.
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Perinatal asphyxia, more appropriately known as hypoxic-ischemic encephalopathy (HIE), is a clinical condition characterized by clinical and laboratory evidence of acute or subacute brain injury resulting from systemic hypoxemia and/or reduced cerebral blood flow in the newborn. It is the commonest etiology for neonatal encephalopathies and accounts for 23% of all term newborn deaths worldwide. While the incidence of severe perinatal asphyxia in resource-rich countries is about 0.1-0.3% of total births, some hospital based studies in Nigeria documented between 3.2% and 30% prevalence and it accounts for between 45% and 83% of perinatal mortalities in some Nigerian studies. Survivors of severe HIE are also at high risk of developing severe cognitive and/or motor impairment, seizure disorders, deafness, and vision loss. Therapeutic hypothermia is currently the gold standard for treating HIE. Other new interventions include high dose Erythropoietin (EPO) and Magnesium sulfate (MgSO4).
EPO is a drug widely known in NICUs for the management of Anemia of prematurity. It has been found to also be a neuroprotective agent, with remarkable neuroprotective and neuro-regenerative effects. Its neuroprotective effects are especially prominent in damages related to ischemia-reperfusion injuries. The neuroprotective properties of Magnesium have also been demonstrated in several animal studies. Magnesium has beneficial effect in cerebral palsy reduction in preterm infants of mothers that received prenatal Magnesium sulfate.
Given the level of poverty in our environment it is most reasonable to attempt to address issues of morbidities more proactively by targeting evidence based cost effective measures that will not only curtail mortality but will also enhance quality of life of survivors of PA. The present study aims to evaluate the neuro protective effects of EPO and MgSO4 in the management of severe PA in term infants at Lagos University Teaching Hospital, Lagos.
All term newbor |
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Ethics |
Ethics List |
12/12/2018 |
Ethics approval attached |
TRUE, Lagos University Teaching Hospital Health research Ethics Committee, Room 107, First floor LUTH administrative block, Lagos, 2517, Nigeria, , 28 Nov 2018, +23415850737, luthethics@yahoo.com, |
TRUE, Lagos University Teaching Hospital Health research Ethics Committee, Room 107, First floor LUTH administrative block, Lagos, 2517, Nigeria, , 28 Nov 2018, +23415850737, luthethics@yahoo.com, 5756_4047_4737.pdf |
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FundingSources List |
12/12/2018 |
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Ezenwa Beatrice, Department of Paediatrics, Lagos University Teaching Hospital, Lagos, , Nigeria, Self Funded, |
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Reporting |
Plan to share IPD |
12/12/2018 |
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Undecided |
No |
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Anticipated trial start date |
23/09/2019 |
To obtain grant for the study |
01 Jan 2019 |
02 Oct 2019 |
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Actual trial start date |
23/09/2019 |
Finally obtained grant for the trial |
15 Jan 2019 |
14 Oct 2019 |
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Recruitment status |
23/09/2019 |
Putting logistics in order before commencing |
Not yet recruiting |
Active, not recruiting |
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Anticipated trial start date |
31/01/2020 |
To be able to put all the trial logistics in order |
02 Oct 2019 |
17 Feb 2020 |
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Actual trial start date |
31/01/2020 |
To be able to put all the trial logistics in order |
14 Oct 2019 |
10 Feb 2020 |
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Anticipated date of last follow up |
31/01/2020 |
To accommodate the new start date |
30 Jun 2022 |
30 Dec 2022 |
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Completion date |
31/01/2020 |
To accommodate the new start date |
31 Jan 2022 |
30 Jul 2020 |