Magnesium Sulphate for Neonatal Asphyxia and Length of Hospital Stay
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 24
SponsorSargodha Medical College
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Major congenital anomalies
neonatal sepsis at admission,
preterm neonates (<37 weeks),
metabolic disorders.
Trial design
Design model
Parallel
Treatments tested in this trial
Magnesium sulphate
DrugIntravenous 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 care
Other interventionStandard clinical supportive care including prompt resuscitation, maintenance of adequate ventilation, correction of metabolic abnormalities, and management of complications without Magnesium Sulphate.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Magnesium sulphate groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
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.
Time frame
Up to 6 monthsSecondary outcomes
1
Neonatal Mortality Rate
Incidence of all-cause mortality during the hospitalization period (recorded as survived or died).
Time frame
up to 6 months2
Seizure Status at Discharge
Clinical assessment of seizure activity and control (categorized as controlled or uncontrolled).
Time frame
Up to 6 months3
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 months4
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 weekLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: