Clinical trial NCT05707962: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Birth Asphyxia
Keywords: birth asphyxia
magnesium sulphate
term infants
Lead sponsor: University of Health Sciences Lahore
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 178
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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:

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.

Primary outcomes:
measure: number of participants died (receiving mgso4)
timeFrame: 6 hours
measure: number of participants diednumber (difference in time of administration)
timeFrame: 24 hours
Secondary outcomes:
measure: number of seizure episode
timeFrame: 6 hours
measure: days in achieving full enteral feed
timeFrame: 1 month
measure: assessment of neurodevelopmental damage
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: children hospital Lahore
name: dr sikandar hayat, MBBS, FCPS
role: STUDY_CHAIR
References: