Neonates With Hypoxic Ischemic Encephalopathy (HIE)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-28
SponsorAssiut University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Neonates with suspected perinatal asphyxia APGAR score < 3 at 5 min.
Neonates whose mother did not receive MgSO4 or caffeine
Disqualifiers
Neonates with Apgar's score > 3 at 5 min
Neonates with congenital malformations
Neonates whose mother had general anasthesia
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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