An interventional study of Magnesium sulphate and Supportive care and standard neonatal intensive care unit care in Duration of Hospitalization and Neonatal Mortality Rate, sponsored by Sargodha Medical College. Not yet recruiting. Open to participants aged Up to 24 Hours. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Sargodha Medical College · Not applicable, Interventional, and Treatment
Neonatal asphyxia causes significant global morbidity, frequently resulting in Hypoxic-Ischemic Encephalopathy (HIE). In resource-limited settings where therapeutic hypothermia is unavailable, affordable neuroprotective options are needed. Intravenous magnesium sulphate blocks NMDA receptors, limiting cellular calcium influx and neuroinflammation. This randomized controlled trial evaluates whether adjuvant intravenous magnesium sulphate (250\text{ mg/kg} within 6 hours of birth) reduces the duration of hospital stay and improves short-term clinical outcomes in term neonates with birth asphyxia.
Perinatal asphyxia triggers secondary brain injury through glutamate release, NMDA receptor overactivation, and intracellular calcium accumulation, leading to Hypoxic-Ischemic Encephalopathy (HIE). Magnesium sulphate acts as a neuroprotective agent by blocking NMDA-gated channels, stabilizing cell membranes, and reducing cerebral edema.
This prospective, randomized trial evaluates 72 term neonates (\ge 37 weeks) admitted with birth asphyxia within 24 hours of birth. Participants are allocated into two equal groups (n = 36 each):
Intervention Group: Receives standard NICU care plus IV Magnesium Sulphate (250\text{ mg/kg} over 30\text{--}60 minutes) within 6 hours of life.
Control Group: Receives standard NICU supportive care alone.
Sargodha Medical College is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Intravenous infusion of Magnesium Sulphate at a dose of 250\\text{ mg/kg} administered over 30\\text{--}60 minutes within 6 hours of birth
Drug: Magnesium sulphate
Term neonates with birth asphyxia who receive standard NICU supportive management alone
Other: Supportive care and standard neonatal intensive care unit care
Intravenous infusion of Magnesium Sulphate at a dose of 250\\text{ mg/kg} administered over 30\\text{--}60 minutes within 6 hours of birth
Standard clinical supportive care including prompt resuscitation, maintenance of adequate ventilation, correction of metabolic abnormalities, and management of complications without Magnesium Sulphate.
Duration of Hospital Stay
Total length of time the neonate requires inpatient care, measured as the number of days from admission to the Neonatal Intensive Care Unit (NICU) until formal hospital discharge.
Time frame: Up to 6 months
Neonatal Mortality Rate
Incidence of all-cause mortality during the hospitalization period (recorded as survived or died).
Time frame: up to 6 months
Seizure Status at Discharge
Clinical assessment of seizure activity and control (categorized as controlled or uncontrolled).
Time frame: Up to 6 months
Time to Establish Oral Feeding
Successful achievement of full oral/suck feeding without relying on tube feeding (categorized as suck feeding established or not established
Time frame: up to 6 months
Neurological Examination at Discharge
Clinical evaluation of neurological recovery, specifically assessing muscle tone and primitive reflexes (categorized as normal or abnormal).
Time frame: With in 1 week
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Jul 2027, 8 months later.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Magnesium Sulfate
Sargodha Medical College