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

HIE Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04705142
• Other study ID #: Ref No. IRB/2019/527/SIMS
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: January 2021
• Source: Services Institute of Medical Sciences, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Hours

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• HIE
• Hypoxia-Ischemia, Brain

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Services Institute of Medical Sciences, Lahore	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Services Institute of Medical Sciences, Pakistan

Country where clinical trial is conducted

Pakistan, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Immediate complications of disease	Reduction in Immediate complications of disease	2 weeks
Primary	Reduction in mortality	Reduction in mortality	2 weeks
Primary	Reduction in hospital stay	Reduction in hospital stay	2 weeks

External Links

•   Reference Study