Magnesium Sulfate in Neonatal HIE"
NCT06342362 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 102
Last updated 2024-04-02
Summary
The study will investigates the neuroprotective effects of intravenous magnesium sulfate in neonates with hypoxic-ischemic encephalopathy (HIE) at a Karachi tertiary care hospital. Using a randomized clinical trial design, the study targets term and near-term newborns with moderate to severe HIE. Data collection involves obtaining informed consent, preparing and administering magnesium sulfate, and assessing outcomes including mortality and morbidity. The study aims to provide insights into improving patient outcomes and clinical practice for neonatal HIE management.
Conditions
- Neonates With HIE
Interventions
- DRUG
-
Magnesium sulfate
Participants would be randomly assigned to either the treatment group (receiving magnesium sulfate) or the control group (receiving a placebo or standard treatment).
- OTHER
-
placebo or standard treatment)
placebo or standard treatment)
Sponsors & Collaborators
-
Sindh Institute of Child Health and Neonatology
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Day
- Max Age
- 30 Days
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-02
- Primary Completion
- 2024-10-02
- Completion
- 2024-12-02
Countries
- Pakistan
Study Locations
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