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

NCT04705142 | Completed Phase 2 DMC

• 1 other identifier: Ref No. IRB/2019/527/SIMS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

HIE

Keywords

HIE, MgSO4

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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.

Drug: MgSo4

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.

Also known as: Conventional Treatment

MgSO4

Eligibility Criteria

• Age: Up to 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Services Institute of Medical Sciences, Pakistan: lead

Study Sites (1)

Services Institute of Medical Sciences, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• Gathwala G, Khera A, Singh J, Balhara B. Magnesium for neuroprotection in birth asphyxia. J Pediatr Neurosci. 2010 Jul;5(2):102-4. doi: 10.4103/1817-1745.76094.

  PMID: 21559152 BACKGROUND

Related Links

• Reference Study

Study Officials

• Dr Uzair Ahmed, MBBS, FCPS

  Associate Prof, Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Blinded Study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Case control study

Study Record Dates

• First Submitted: November 21, 2020
• First Posted: January 12, 2021
• Study Start: May 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)