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

Birth Asphyxia Clinical Trial

Official title:

A Multicentre Double Blind Trial of the Neuroprotective Efficacy of Postnatal Magnesium Sulphate in Term/Near Term Infants With Moderate to Severe Birth Asphyxia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05707962
• Other study ID #: IRB/2022/1018/SIMS
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 24, 2023
• Est. completion date: August 10, 2023

Study information

• Verified date: February 2023
• Source: University of Health Sciences Lahore
• Contact: komal khadim hussain, MBBS
• Phone: 03056714280
• Email: drkomalkhadimhussain[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recent evidence from animal studies and small human studies it has become clear that giving Magnesium Sulphate to term or nearterm babies with moderate to severe birth/perinatal asphyxia reduces both mortality and morbidity.

Magnesium Sulphate as a drug has been in clinical use for decades; its pharmacokinetics, safety profile and mode of action are well known. It is cheap and readily available in Pakistan thus providing an opportunity to confirm or refute the efficacy of Magnesium Sulphate in birth/perinatal asphyxia.

With this in mind the following pragmatic study has been designed using the current practices and available resources:

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 178
• Est. completion date: August 10, 2023
• Est. primary completion date: July 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 24 Hours

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Birth Asphyxia

Intervention

Drug:
• Magnesium sulfate
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Health Sciences Lahore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	number of seizure episode	Frequency of seizures in the two groups and number of days to achieve seizure control.	6 hours
Secondary	days in achieving full enteral feed	Number of days to achieve oral feed.	1 month
Secondary	assessment of neurodevelopmental damage	Neurodevelopmental disability in survivors at 18 months of age as assessed by a developmental pediatrician blinded to the study groups using one standard developmental screening method in all babies	1 month