Magnesium Sulphate for Neonatal Asphyxia and Length of Hospital Stay

NCT07835529 | Not Yet Recruiting

• 1 other identifier: SMC-PED-2026-0015
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Duration of Hospitalization; Neonatal Mortality Rate

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 6 months

Secondary Outcomes (4)

• Neonatal Mortality Rate

  up to 6 months

• Seizure Status at Discharge

  Up to 6 months

• Time to Establish Oral Feeding

  up to 6 months

• Neurological Examination at Discharge

  With in 1 week

Study Arms (2)

Magnesium sulphate group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

Term neonates with birth asphyxia who receive standard NICU supportive management alone

Other: Supportive care and standard neonatal intensive care unit care

Interventions

Magnesium sulphate DRUG

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

Magnesium sulphate group

Supportive care and standard neonatal intensive care unit care OTHER

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

Control group

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Term neonates (gestational age more than 37 weeks),
• age less than 24 hours,
• diagnosed with birth asphyxia (Apgar score less than 5 at 5 minutes or 4)Evidence of hypoxic-ischemic injury within 6 hours of birth).

You may not qualify if:

• Major congenital anomalies
• neonatal sepsis at admission,
• preterm neonates (\<37 weeks),
• metabolic disorders.

Sponsors & Collaborators

• Sargodha Medical College: lead

MeSH Terms

Interventions

Magnesium Sulfate; Palliative Care

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 23, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09