search
Back to results

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

Primary Purpose

Birth Asphyxia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Magnesium sulfate
Sponsored by
University of Health Sciences Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Birth Asphyxia focused on measuring birth asphyxia, magnesium sulphate, term infants

Eligibility Criteria

1 Hour - 24 Hours (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    intervention group

    non intervention group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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
    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.

    Secondary Outcome Measures

    number of seizure episode
    Frequency of seizures in the two groups and number of days to achieve seizure control.
    days in achieving full enteral feed
    Number of days to achieve oral feed.
    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

    Full Information

    First Posted
    January 22, 2023
    Last Updated
    February 12, 2023
    Sponsor
    University of Health Sciences Lahore
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05707962
    Brief Title
    Neuroprotective Efficacy of Postnatal Magnesium Sulphate in Term Infants With Birth Asphyxia
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 24, 2023 (Anticipated)
    Primary Completion Date
    July 24, 2023 (Anticipated)
    Study Completion Date
    August 10, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Health Sciences Lahore

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed 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:

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Birth Asphyxia
    Keywords
    birth asphyxia, magnesium sulphate, term infants

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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
    Masking
    ParticipantCare Provider
    Masking Description
    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
    Allocation
    Randomized
    Enrollment
    178 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    non intervention group
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Magnesium sulfate
    Other Intervention Name(s)
    neuroprotective agent
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    number of participants died (receiving mgso4)
    Description
    Mortality between the two groups (Standard management vs Magnesium Sulphate treated group). Further analyzed by the stage of asphyxia
    Time Frame
    6 hours
    Title
    number of participants diednumber (difference in time of administration)
    Description
    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.
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    number of seizure episode
    Description
    Frequency of seizures in the two groups and number of days to achieve seizure control.
    Time Frame
    6 hours
    Title
    days in achieving full enteral feed
    Description
    Number of days to achieve oral feed.
    Time Frame
    1 month
    Title
    assessment of neurodevelopmental damage
    Description
    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
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Hour
    Maximum Age & Unit of Time
    24 Hours
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    komal khadim hussain, MBBS
    Phone
    03056714280
    Email
    drkomalkhadimhussain@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    muhammad asif siddique, MBBS, FCPS
    Phone
    03315009046
    Email
    drasifrmc@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    dr sikandar hayat, MBBS, FCPS
    Organizational Affiliation
    children hospital Lahore
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Data will be collected on data record forms (DRFs) given in appendix 1. Short-term outcomes include initiation of feed in days, seizure control in days, duration of stay, cranial ultrasound findings and EEG at discharge or last reported before death and discharge or death will be recorded. Cranial ultrasound and EEG will be performed by the same sonologist and neurologist. The developmental assessment will be done at 18 months of age by the same neurodevelopmental pediatrician, blinded to the study using Griffiths scoring system.

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs