Neuroprotective Outcomes of Magnesium Sulfate in Neonates With Hypoxic-Ischemic Encephalopathy (HIE) at Tertiary Care Hospital of Karachi
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Neuroprotective effects
研究概览
简要总结
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.
详细描述
Objective:
• To determine the neuroprotective outcomes of intravenous magnesium sulphate in neonates with hypoxic ischemic encephalopathy (HIE) at a tertiary care hospital of Karachi.
Methodology:
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Study Setting: This is a prospective study; and will be conducted at tertiary care hospital of Karachi (Sindh Institute of Child Health and Neonatology, K-5).
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Study Design: Rndomized clinical Trial
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Target Population: The study population will be all term and near term newborns (≥35 completed weeks) with moderate to severe HIE.
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Inclusion Criteria: All Late preterm and term newborn with hypoxic ischemic encephalopathy (HIE) on basis of sarnat score and reaching in our unit within 6 hours of life will be the part of our trial.
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Exclusion Criteria:
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Newborns of less than 34 weeks, with dimorphism, comorbidities or arriving after 6 hours of birth, will be excluded.
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Pre-existing medical conditions that may interfere with the assessment of neuroprotective outcomes.
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Congenital anomalies or genetic disorders affecting neurological function.
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Allergy or known adverse reactions to magnesium sulfate.
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Participation in another concurrent clinical trial involving investigational drugs or interventions.
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Inability to obtain informed consent from parents or guardians.
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Medical Intervention: Magnesium sulphate as infusion will be commenced to cases. Control will be treated as per unit protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Late preterm and term newborn with hypoxic ischemic encephalopathy (HIE) on basis of sarnat score and reaching in our unit within 6 hours of life will be the part of our trial.
排除标准
- •Newborns of less than 34 weeks, with dimorphism, comorbidities or arriving after 6 hours of birth, will be excluded.
- •Pre-existing medical conditions that may interfere with the assessment of neuroprotective outcomes.
- •Congenital anomalies or genetic disorders affecting neurological function.
- •Allergy or known adverse reactions to magnesium sulfate.
- •Participation in another concurrent clinical trial involving investigational drugs or interventions.
- •Inability to obtain informed consent from parents or guardians.
研究组 & 干预措施
treatment group (receiving 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).
干预措施: Magnesium sulfate (Drug)
the control group (receiving a placebo or standard treatment)
Participants would be randomly assigned to either the treatment group (receiving
干预措施: placebo or standard treatment) (Other)
结局指标
主要结局
Neuroprotective effects
时间窗: 6 months
Neuroprotective effects: decrease in the frequency or duration of seizures, ability to suck
次要结局
未报告次要终点
研究者
Sher Wali Khan
fellow Neonatologist
Sindh Institute of Child Health and Neonatology