Magnesium Sulphate for Neonatal Asphyxia and Length of Hospital Stay

N/ANot Yet RecruitingNCT07835529

Sargodha Medical College72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Duration of Hospitalization

Interventions

Magnesium sulphateDRUG

Intravenous infusion of Magnesium Sulphate at a dose of 250\\text{ mg/kg} administered over 30\\text{--}60 minutes within 6 hours of birth

Supportive care and standard neonatal intensive care unit careOTHER

Standard clinical supportive care including prompt resuscitation, maintenance of adequate ventilation, correction of metabolic abnormalities, and management of complications without Magnesium Sulphate.

Eligibility

Sex: ALLMax age: 24 Hours

Medical Language ↔ Plain English

Inclusion Criteria: 1. Term neonates (gestational age more than 37 weeks), 2. age less than 24 hours, 3. diagnosed with birth asphyxia (Apgar score less than 5 at 5 minutes or 4)Evidence of hypoxic-ischemic injury within 6 hours of birth). Exclusion Criteria: 1. Major congenital anomalies 2. neonatal sepsis at admission, 3. preterm neonates (\<37 weeks), 4. metabolic disorders.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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