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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04705142
Recruitment Status : Completed
First Posted : January 12, 2021
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Services Institute of Medical Sciences, Pakistan

Study Description
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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
HIE Drug: MgSo4 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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Case 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 : December 30, 2020
Actual Study Completion Date : December 30, 2020

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Arms and Interventions
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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 Name: Conventional Treatment


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04705142


Locations
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Pakistan
Services Institute of Medical Sciences, Lahore
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
Services Institute of Medical Sciences, Pakistan
Investigators
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Study Director: Dr Uzair Ahmed, MBBS, FCPS Associate Prof, Surgery
More Information
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Additional Information:

Publications:

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Responsible Party: Services Institute of Medical Sciences, Pakistan
ClinicalTrials.gov Identifier: NCT04705142    
Other Study ID Numbers: Ref No. IRB/2019/527/SIMS
First Posted: January 12, 2021    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: After family consent, decision will be reviewed

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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:
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Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Central Nervous System Diseases
Nervous System Diseases
Hypoxia
 Signs and Symptoms, Respiratory
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain