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临床试验/NCT07652801
NCT07652801尚未招募3 期

COMPARISON OF OUTCOME OF HYPOXIC ENCEPHLOPATHY MANAGED WITH MgSO4 AND MELATONIN VERSUS MgSO4 ALONE

University of Child Health Sciences and Children's Hospital, Lahore0 个研究点目标入组 80 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
80

研究概览

简要总结

COMPARISON OF OUTCOME OF HYPOXIC ISCHEMIC ENCEPHALOPATHY MANAGED WITH COMBINATION OF MAGNESIUM SULPHATE AND MELATONIN VERSUS MAGNESIUM SULPHATE ALONE Participants of group A will have 3 doses of MgSO4 infusion at rate of 250mg/kg per day intravenous over 1hour on day 0,1,2 Participants of group B will have 5 doses of Melatonin 10mg/kg for 5days along with MgSO4. They will undergo reassessment of arterial PH and serum LDH after completion of therapy. They will be followed for length of hospital stay and time until feed is initiated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Hour 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Both genders
  • Born at term i.e >37weeks gestation
  • With APGAR score<5 at 1min
  • Umblical artery acidemia(PH<7 or base deficit>12mmol/L
  • Evidence of atleast moderate grade ofHIE on sarnat scoring.

排除标准

  • With congenital anamolies
  • Intrauterine growth retadation
  • suspicion of neonatal sepsis
  • Congenital heart disese and those with IEM.

研究者

发起方
University of Child Health Sciences and Children's Hospital, Lahore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Akasha Rehman

DOCTOR

University of Child Health Sciences and Children's Hospital, Lahore

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