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

Sponsor
Services Institute of Medical Sciences, Pakistan (Other)
Overall Status
Completed
CT.gov ID
NCT04705142
Collaborator
(none)
200
Enrollment
1
Location
1
Arm
20
Actual Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Case control studyCase control study
Masking:
None (Open Label)
Masking Description:
Blinded Study
Primary Purpose:
Treatment
Official Title:
Beneficial Effect of Intravenous Magnesium Sulphate in Term Neonates With Hypoxic Ischemic Encephalopathy(HIE)
Actual Study Start Date :
May 1, 2019
Actual Primary Completion Date :
Dec 30, 2020
Actual Study Completion Date :
Dec 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: MgSo4
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reduction in Immediate complications of disease [2 weeks]

      Reduction in Immediate complications of disease

    2. Reduction in mortality [2 weeks]

      Reduction in mortality

    3. Reduction in hospital stay [2 weeks]

      Reduction in hospital stay

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 6 Hours
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Services Institute of Medical Sciences, Lahore Lahore Punjab Pakistan 54000

    Sponsors and Collaborators

    • Services Institute of Medical Sciences, Pakistan

    Investigators

    • Study Director: Dr Uzair Ahmed, MBBS, FCPS, Associate Prof, Surgery

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Services Institute of Medical Sciences, Pakistan
    ClinicalTrials.gov Identifier:
    NCT04705142
    Other Study ID Numbers:
    • Ref No. IRB/2019/527/SIMS
    First Posted:
    Jan 12, 2021
    Last Update Posted:
    Jan 12, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Services Institute of Medical Sciences, Pakistan
    HIE, MgSO4
    Additional relevant MeSH terms:
    Brain Diseases
    Brain Ischemia
    Hypoxia-Ischemia, Brain

    Study Results

    No Results Posted as of Jan 12, 2021