An observational study in Hypoxic Ischemic Encephalopathy (HIE), sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2024-11-19.
Sponsored by Assiut University · Observational
Assessment of the potential neuroprotective effect of magnesium sulphate and caffeine in treating asphyxiated newborns and improvement of the neurological outcome of Hypoxic Ischemic Encephalopathy in Assiut university hospital of Children
Encephalopathy in neonates is broadly defined as brain dysfunction in a newborn manifesting as alteration in mental status and abnormal neurologic examination. Neonatal encephalopathy (NE) may result from acute or chronic hypoxic-ischemic injury, brain malformations, vascular injuries (including stroke), inborn errors of metabolism, and other causes. Hypoxic-ischemic encephalopathy (HIE) is a specific diagnosis and applies only when a neonate has encephalopathy that is known or highly suspected to be due to a hypoxic-ischemic event.
Perinatal asphyxia is a condition where hypoxaemia and acidosis are present in the fetus or the newborn infants. It is a failure newborn to initiate spontaneous, sustained, and vigorous respiration effort at birth. It is also defined as a failure to initiate spontaneous respirations and/or a 5-minute Apgar score of less than 7: the most commonly used indicator in the identification of birth asphyxia in resource limited settings . About 20% - 30% of asphyxiated newborns who develop hypoxic ischemic encephalopathy (HIE) die during the neonatal period, and one third to one half of survivors are left with cerebral palsy and mental retardation . Survivors present with several short and long term morbidities, including: seizure disorders, tone abnormalities, feeding difficulties, delayed developmental milestones, learning difficulties, cerebral palsy and mental retardation. The frequency of severe perinatal asphyxia complications, hypoxic ischemic encephalopathy (HIE) and incidence of up to 26.5/1000 live births is unacceptably high despite advances in perinatal care . Encephalopathy occurs in 50% to 60% of patients with severe perinatal asphyxia. Among patients with moderate HIE, 10% to 20% die, and 30% to 40% develop neurodevelopmental disorders, whereas 50% of patients with severe HIE die and almost all survivors develop neurodevelopmental deficits Neuro-science research has revealed our understanding of the mechanisms by perinatal asphyxia neuronal damage and adverse consequences. Asphyxia leads to two types of cerebral injuries: the primary neuronal injury that occurs at the time of hypoxic-ischemic insults and the secondary cerebral injury that occurs over hours to days after accumulation of excessive intra-neuronal calcium through stimulation of the excitatory N-methyl-D-aspartate (NMDA) glutamate receptors, which triggers apoptosis of the affected neurons . Magnesium is a naturally occurring NMDA receptor antagonist that blocks neuronal influx of calcium within the ion channels. This block is voltage-dependent and is overcome during axonal depolarization that occurs in hypoxic-ischemic insults. If the extra-cellular magnesium concentration is increased, this blockade can be restored. Magnesium sulphate may also have direct actions on mitochondrial activity, anticonvulsant properties and hemodynamic effects by increasing cerebral blood flow. Some data also suggest that MgSO4 may serve an anti-apoptotic role and prevent neuronal cell loss .
Clinical studies have shown that caffeine also has neuroprotective effects in premature infants by alleviating hypoxia induced white matter damage, and improving ventilation function and brain self-regulation In addition, caffeine has been shown to reduce the apoptosis of developing brain neurons, ventricular enlargement, and white matter loss caused by hypoxia.
241 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 85 are open to participants now.
This study's planned enrollment of 72 is below the median of 100 across 88 observational studies indexed under Hypoxia-Ischemia, Brain.
Browse Hypoxia-Ischemia, Brain studies →Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.
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Neonates with Hypoxic Ischemic Encephalopathy (HIE) .Encephalopathy in neonates is broadly defined brain dysfunction in a newborn manifesting as alteration in mental status and abnormal neurologic examination. Neonatal encephalopathy (NE) may result from acute or chronic hypoxic-ischemic injury, brain malformations, vascular injuries (including stroke), inborn errors of metabolism, and other causes. Hypoxic-ischemic encephalopathy (HIE) is a specific diagnosis and applies only when a neonate has encephalopathy that is known or highly suspected to be due to a hypoxic-ischemic event.
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Assessment of the potential neuroprotective effect of magnesium sulphate and caffeine in improvement of the neurological outcome of hypoxic ischemic encephalopathy in Assuit university hospital.
Assesment of neuroprotective effect of magnesium sulphate and caffeine by : 1. Determine the benefit of magnesium sulphate and caffeine on perinatal asphyxia. 2. Determine the effect of magnesium sulphate and caffeine on neurological outcome in severe perinatal Asphyxia. 3. Determine the effect of magnesium sulphate and caffeine on reduction of duration of Admission/hospitalization.
Time frame: Baseline
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This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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