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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04705142

Enrollment

200

Registered

2021-01-12

Start date

2019-05-01

Completion date

2020-12-30

Last updated

2021-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIE

Keywords

HIE, MgSO4

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.

Interventions

DRUGMgSo4

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Masking description

Blinded Study

Intervention model description

Case control study

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Hours

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026