Combined neuroprotective effect of magnesium sulfate plus therapeutic hypothermia versus therapeutic hypothermia alone in the management of term and near term infants with hypoxic ischaemic encephalopathy An open labelled randomised controlled trial

Pt B D sharma health university0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•A) Essential criterias : ( all three criterias should be met )
•1. Infants of more than 36 weeks of gestational period.
•2. Admitted to NICU within 6 hrs of birth.
•3. Birth weight more than 2000gm.
•B) Evidence of birth asphyxia ( any one of the following should be met )
•1. Apgar score less than 5 at 5 minutes after birth due to birth asphyxia/perinatal depression.
•2. Continued need for resuscitation, including endotracheal or mask ventilation at 5 minutes after birth.
•3. Acidosis within 60 minutes of birth defined as any occurrence of umbilical cord/arterial capillary pH less than 7.00
•4. Base deficit more than 16 mmol/l in umbilical cord or any blood sample taken within 60 minutes of birth
•C) Evidence of encephalopathy ( any one of the following should be met )
•1. Clinical seizures
•2. Evidence of moderate to severe encephalopathy, consisting of altered state of consciousness including lethargy, stupor or coma and at least one of the following;
•a. Hypotonia
•b. Abnormal reflexes including occulomotor or pupillary reflexes
•c. Absent or weak suck

•1. Babies with gross congenital malformation.
•2. Treatment of mother with magnesium sulphate for pregnancy induced hypertension.
•3. Babies with little chance to survive.( Apgar score less than 1 at 10 minutes )
•4. Infants received after 6 hrs of birth.

发起方

Pt B D sharma health university