Duration of HospitalizationNCT07835529
Magnesium Sulphate for Neonatal Asphyxia and Length of Hospital Stay
A study testing Magnesium sulphate and Supportive care and standard neonatal intensive care unit care in people with Duration of Hospitalization and Neonatal Mortality Rate, run by Sargodha Medical College.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Duration of Hospitalization, Neonatal Mortality Rate
- What is being tested?
- Magnesium sulphate and Supportive care and standard neonatal intensive care unit care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- Major congenital anomalies
- neonatal sepsis at admission,
- preterm neonates (<37 weeks),
- metabolic disorders.
About this study
Official title: Use of Magnesium Sulphate in Neonatal Asphyxia and Its Effect on Duration of Hospital Stay
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.
Read the detailed description
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.
- Being tested
- Magnesium sulphate, Supportive care and standard neonatal intensive care unit care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Magnesium sulphate |
| Control group | Active comparator | Term neonates with birth asphyxia who receive standard NICU supportive management alone Receives: Other: Supportive care and standard neonatal intensive care unit care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months
Secondary outcomes (4)
Neonatal Mortality Rate
Incidence of all-cause mortality during the hospitalization period (recorded as survived or died).
Measured: up to 6 months
Seizure Status at Discharge
Clinical assessment of seizure activity and control (categorized as controlled or uncontrolled).
Measured: 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
Measured: 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).
Measured: With in 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duration of HospitalizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sargodha Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835529
- Sponsor's protocol ID
- SMC-PED-2026-0015
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Magnesium Sulphate in Neonatal Asphyxia and Its Effect on Duration of Hospital Stay
- ClinicalTrials.gov ID
- NCT07835529
- Acronym / sponsor ID
- SMC-PED-2026-0015
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Sargodha Medical CollegeUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulphate group | Experimental | Drug: Magnesium sulphateIntravenous infusion of Magnesium Sulphate at a dose of 250\text{ mg/kg} administered over 30\text{--}60 minutes within 6 hours of birth |
| Control group | Active comparator | Other: Supportive care and standard neonatal intensive care unit careTerm neonates with birth asphyxia who receive standard NICU supportive management alone |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- Major congenital anomalies
- neonatal sepsis at admission,
- preterm neonates (<37 weeks),
- metabolic disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium sulphateIntravenous 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 group |
| Supportive care and standard neonatal intensive care unit careStandard clinical supportive care including prompt resuscitation, maintenance of adequate ventilation, correction of metabolic abnormalities, and management of complications without Magnesium Sulphate. | Other | Control group |
Primary outcome
Duration of Hospital Stay
Time frame: Up to 6 months
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.
4 secondary outcomes
Neonatal Mortality Rate
Time frame: up to 6 months
Seizure Status at Discharge
Time frame: Up to 6 months
Time to Establish Oral Feeding
Time frame: up to 6 months
Neurological Examination at Discharge
Time frame: With in 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium sulphate and Supportive care and standard neonatal intensive care unit care in people with Duration of Hospitalization and Neonatal Mortality Rate, run by Sargodha Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Hospital Stay (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.