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

Phase 2

Completed

• Conditions: HIE
• Interventions: Drug: MgSo4

• Registration Number: NCT04705142
• Lead Sponsor: Services Institute of Medical Sciences, Pakistan

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2020-11-21
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-11
• Last Update Submitted: 2021-01-11
• Study First Posted: 2021-01-12
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MgSO4	MgSo4	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.

Primary Outcome Measures

Name	Time	Method
Reduction in Immediate complications of disease	2 weeks	Reduction in Immediate complications of disease
Reduction in mortality	2 weeks	Reduction in mortality
Reduction in hospital stay	2 weeks	Reduction in hospital stay

Trial Locations

Locations (1)

Services Institute of Medical Sciences, Lahore; 🇵🇰 Lahore, Punjab, Pakistan