Neuroprotective Efficacy of Postnatal Magnesium Sulphate in Term Infants With Birth Asphyxia

NCT05707962 | Completed

• 1 other identifier: IRB/2022/1018/SIMS
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

Birth/Perinatal asphyxia in Pakistan continues to be a leading cause of neonatal mortality and morbidity. It is estimated that around 80 to 120,000 neonates either suffer from or die from birth/perinatal asphyxia every year. In addition to the large number of deaths a larger number of babies who survive suffer from neuro-developmental disorders adding to the health burden to the society and the nation. To date other than prevention (which requires global efforts to improve maternal education and health care) the therapies available to treat infants who have suffered from birth asphyxia have been either technically too complex or extremely expensive.

Conditions

Birth Asphyxia

Keywords

birth asphyxia; magnesium sulphate; term infants

Outcome Measures

Primary Outcomes (2)

• number of participants died (receiving mgso4)

  Mortality between the two groups (Standard management vs Magnesium Sulphate treated group). Further analyzed by the stage of asphyxia

  6 hours

• number of participants diednumber (difference in time of administration)

  Mortality between the two groups (Standard management vs Magnesium Sulphate treated group) in those where magnesium sulphate was given within six hours of birth and those given later than six hours of birth.

  24 hours

Secondary Outcomes (3)

• number of seizure episode

  6 hours

• days in achieving full enteral feed

  1 month

• assessment of neurodevelopmental damage

  1 month

Study Arms (2)

intervention group

EXPERIMENTAL

All babies with moderate or severe Hypoxic Ischemic Encephalopathy fulfilling the inclusion criteria will be randomized to receive either the standard treatment (oxygen and fluid therapy along with anticonvulsants if required) plus 3.0 ml/kg of 10% dextrose water given over 30 minutes, three dose given 24 hours apart or to receive standard treatment PLUS three doses of Magnesium Sulphate infusion given over 30 minutes at 250 mg/kg per dose given 24 hours apart. The volume of infusion shall be adjusted with 10% dextrose water to make it up to 3.0 ml. The resulting reconstituted solution for intravenous infusion shall be 8.3% Magnesium Sulphate delivered over 30 minutes at a rate of 0.1 ml/kg/minute i.e. 8.3 mg/kg/minute. The treatment should be started as soon after birth as possible and not later than 24 hours of life. The babies who meet the exclusion criteria will not be continued into the study.

Drug: Magnesium sulfate

non intervention group

NO INTERVENTION

All babies with moderate or severe Hypoxic Ischemic Encephalopathy fulfilling the inclusion criteria will be randomized to receive either the standard treatment (oxygen and fluid therapy along with anticonvulsants if required) plus 3.0 ml/kg of 10% dextrose water given over 30 minutes, three dose given 24 hours apart or to receive standard treatment PLUS three doses of Magnesium Sulphate infusion given over 30 minutes at 250 mg/kg per dose given 24 hours apart. The volume of infusion shall be adjusted with 10% dextrose water to make it up to 3.0 ml. The resulting reconstituted solution for intravenous infusion shall be 8.3% Magnesium Sulphate delivered over 30 minutes at a rate of 0.1 ml/kg/minute i.e. 8.3 mg/kg/minute. The treatment should be started as soon after birth as possible and not later than 24 hours of life. The babies who meet the exclusion criteria will not be continued into the study.

Interventions

Magnesium sulfate DRUG

All babies with moderate or severe Hypoxic Ischemic Encephalopathy fulfilling the inclusion criteria will be randomized to receive either the standard treatment (oxygen and fluid therapy along with anticonvulsants if required) plus 3.0 ml/kg of 10% dextrose water given over 30 minutes, three dose given 24 hours apart or to receive standard treatment PLUS three doses of Magnesium Sulphate infusion given over 30 minutes at 250 mg/kg per dose given 24 hours apart. The volume of infusion shall be adjusted with 10% dextrose water to make it up to 3.0 ml. The resulting reconstituted solution for intravenous infusion shall be 8.3% Magnesium Sulphate delivered over 30 minutes at a rate of 0.1 ml/kg/minute i.e. 8.3 mg/kg/minute. The treatment should be started as soon after birth as possible and not later than 24 hours of life. The babies who meet the exclusion criteria will not be continued into the study.

Also known as: neuroprotective agent

intervention group

Eligibility Criteria

• Age: 1 Hour - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Term and near term infants (≥35 weeks gestation) with moderate to severe birth asphyxia Age at admission \< 24 hours

You may not qualify if:

• Babies who could not be given first injection before 24 hours of age
• Infants with major congenital malformations, sepsis, congenital heart defects, Intracranial hemorrhage and surgical problems
• Babies received intubated in emergency
• Babies receiving therapeutic hypothermia
• Infants with disorders of metabolism
• Infants in whom cause other than asphyxia is established as the reason for not initiating or sustaining breathing at birth.

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

Study Sites (1)

services hospital Pakistan

Lahore, Punjab Province, 54610, Pakistan

Location

MeSH Terms

Conditions

Asphyxia Neonatorum

Interventions

Magnesium Sulfate; Neuroprotective Agents

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• dr sikandar hayat, MBBS, FCPS

  children hospital Lahore

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: As soon as parental consent has been obtained the baby will be allocated to one arm of the study using randomly shuffled sealed brown envelopes containing the allocation arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: All babies with moderate or severe Hypoxic Ischemic Encephalopathy fulfilling the inclusion criteria will be randomized to receive either the standard treatment (oxygen and fluid therapy along with anticonvulsants if required) plus 3.0 ml/kg of 10% dextrose water given over 30 minutes, three dose given 24 hours apart or to receive standard treatment PLUS three doses of Magnesium Sulphate infusion given over 30 minutes at 250 mg/kg per dose given 24 hours apart. The volume of infusion shall be adjusted with 10% dextrose water to make it

Study Record Dates

• First Submitted: January 22, 2023
• First Posted: February 1, 2023
• Study Start: March 24, 2023
• Primary Completion: July 24, 2023
• Study Completion: August 10, 2023
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)