europrotective effects of hypothermia combined with inhaled xenon following perinatal asphyxia: a randomised controlled trial

Imperial College London (UK)0 个研究点目标入组 92 人开始时间: 2009年7月30日最近更新: 2017年4月18日

适应症

试验速览

暂无简介。

•1. Infants 36 to 43 weeks gestation (either sex) with at least one of the following:
•1.1. Apgar score of less than 5 at 10 minutes after birth
•1.2. Continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth
•1.3. Acidosis defined as pH less than 7.00 and/or base deficit x 16 mmol/L in umbilical cord blood sample or any blood sample within 60 minutes of birth (arterial or venous blood)
•2. Moderate to severe encephalopathy consisting of altered state of consciousness (reduced or absent response to stimulation) and hypotonia, and abnormal primitive reflexes (weak or absent suck or Moro response). Clinical severity of hypoxic-ischaemic encephalopathy (HIE) will be assessed by Thompson encephalopathy score, and modified Sarnat score
•3. At least 30 minutes duration of amplitude integrated EEG (aEEG) recording that shows moderately abnormal or suppressed background aEEG activity or seizures

•1. If treatment with hypothermia is delayed beyond 6 hours, or infants are expected to be greater than 12 hours of age at the time of randomisation
•2. Infants with ventilatory oxygen requirement greater than 70%
•3. Attending clinician considers infant not suitable to participate because of other serious congenital abnormalities, or the infant's condition appears terminal

发起方

Imperial College London (UK)