Beneficial Effect of Intravenous Magnesium Sulphate in Term Neonates With Hypoxic Ischemic Encephalopathy(HIE)

Study Overview
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Brief Summary
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Neonatal mortality rate is the highest in Pakistan. And Birth Asphyxia is one of the main reversible causes. Outcomes related to birth asphyxia can be improved, if intervention done in time with proper measures. MgSO4 is cheaper and easily available drug.

Detailed Description
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Some studies showed positive results if given within 6 hours of birth asphyxia, whereas some are not supportive. But still less know about this drug, especially in low income countries. Objective of this study is to see beneficial effects of MgSO4 in neonates presenting with birth asphyxia.

Official Title
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Beneficial Effect of Intravenous Magnesium Sulphate in Term Neonates With Hypoxic Ischemic Encephalopathy(HIE)

Conditions
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HIE

Intervention / Treatment
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* Drug: MgSo4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: After informed consent, any child who is term, inborn or out born fulfilling the definition of hypoxic ischemic encephalopathy according to history, apgar or scoring system and reaching within 6 hours of delivery in nursery department of pediatric medicine unit-II, Services Hospital, Lahore Exclusion Criteria: Preterm Syndromic/dysmorphic child Term child with HIE and arriving after 6 hours of life. Term child with unrelated co morbidities eg congenital heart defects, Renal failure etc

Ages Eligible for Study
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Maximum Age: 6 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Case control study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MgSO4<br>MgSO4 1st dose within 6 hours of life @250mg/kg,2nd after 24 hours of life @250mg/kg, 3rd after 48 hours of life @250mg/kg. Monitoring and Protective measures: Before and during administration of MgSO4, B.P, Capillary refill time, Heart rate and respiratory rate will be assessed closely i-e on 10 minutes interval, infusion of MgSO4 will be give over 30 minutes and baby will be monitored every 15 minutes interval after completion of infusion as well for 1 hour. | Drug: MgSo4<br>* Before and during administration of MgSO4, B.P, Capillary refill time, Heart rate and respiratory rate will be assessed closely i-e on 10 minutes interval, infusion of MgSO4 will be give over 30 minutes and baby will be monitored every 15 minutes interval after completion of infusion as well for 1 hour.<br>* Other names: Conventional Treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Immediate complications of disease | Reduction in Immediate complications of disease | 2 weeks | 
| Reduction in mortality | Reduction in mortality | 2 weeks | 
| Reduction in hospital stay | Reduction in hospital stay | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIE, MgSO4