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Completed

NCT Number: NCT04705142

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

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.

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Key information

Conditions

HIE

Age range

Up to 6 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Services Institute of Medical Sciences, Lahore

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MgSO4

Drug

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.

Other names: Conventional Treatment

Primary outcomes

  1. Reduction in Immediate complications of disease

    Time frame: 2 weeks

    Reduction in Immediate complications of disease

  2. Reduction in mortality

    Time frame: 2 weeks

    Reduction in mortality

  3. Reduction in hospital stay

    Time frame: 2 weeks

    Reduction in hospital stay

Sponsors and collaborators

Lead sponsor

Services Institute of Medical Sciences, Pakistan

Other Gov

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 12, 2021
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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