---
title: Beneficial Effect of Intravenous Magnesium Sulphate in Term Neonates With Hypoxic Ischemic Encephalopathy(HIE)
nct_id: NCT04705142
overall_status: COMPLETED
phase: PHASE2
sponsor: Services Institute of Medical Sciences, Pakistan
study_type: INTERVENTIONAL
primary_condition: HIE
countries: Pakistan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04705142.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04705142"
ct_last_update_post_date: 2021-01-12
last_seen_at: "2026-05-12T06:18:20.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Beneficial Effect of Intravenous Magnesium Sulphate in Term Neonates With Hypoxic Ischemic Encephalopathy(HIE)

**NCT ID:** [NCT04705142](https://clinicaltrials.gov/study/NCT04705142)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 200
- **Lead Sponsor:** Services Institute of Medical Sciences, Pakistan
- **Conditions:** HIE
- **Start Date:** 2019-05-01
- **Completion Date:** 2020-12-30
- **CT.gov Last Update:** 2021-01-12

## 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.

## Eligibility

- **Maximum age:** 6 Hours
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **MgSO4** (EXPERIMENTAL) — 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.

## Interventions

- **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.

## Primary Outcomes

- **Reduction in Immediate complications of disease** _(time frame: 2 weeks)_ — Reduction in Immediate complications of disease
- **Reduction in mortality** _(time frame: 2 weeks)_ — Reduction in mortality
- **Reduction in hospital stay** _(time frame: 2 weeks)_ — Reduction in hospital stay

## Locations (1)

- Services Institute of Medical Sciences, Lahore, Lahore, Punjab Province, Pakistan

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.services institute of medical sciences, lahore|lahore|punjab province|pakistan` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04705142.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04705142*  
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