CTRI/2021/03/031798尚未招募4 期
acetylcysteine as an adjunct to therapeutic hypothermia in the management of term or late preterm neonates with hypoxic ischemic encephalopathy to prevent the composite outcome of death or major neurodevelopment disability at 6 months postnatal age: a randomized, double-blind, placebo- controlled trial - HypNAC
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion criteria (The baby should meet criteria from either A or B, plus the criteria in C)
- •1. Inborn babies with gestational age >= 36 weeks with ABG (umbilical cord or 1st postnatal hour) pH <=7 or Base deficit >= 12 meq/L
- •2. Any one of the below mentioned criteria
- •i. APGAR <=5 at 10 min
- •ii. Assisted ventilation for at least 10 min after birth
- •iii. History of acute perinatal event- intrapartum fetal distress, cord prolapse, placental abruption, maternal trauma, uterine rupture, cardiac arrest
- •3. Presence of moderate or severe encephalopathy by clinical examination (Modified Sarnat staging).
排除标准
- •Exclusion criteria
- •1) Infants >6 hours of age at the time of randomization.
- •2) Major congenital abnormalities.
- •3) Babies who do not have spontaneous respiration at 20 minutes of life
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