europrotective effects of hypothermia combined with inhaled xenon following perinatal asphyxia - the TOBY Xe trial - The TOBY Xe Trial version 001

Imperial College London0 个研究点目标入组 92 人开始时间: 2010年3月17日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•A Infants 36 to 43 weeks gestation with at least one of the following:
•(a) Apgar score of < or =5 at 10 minutes after birth;
•(b) Continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth;
•(c) Acidosis defined as pH <7.00 and/or base deficit >15 mmol/L in umbilical cord blood sample or any blood sample within 60 minutes of birth (arterial or venous blood).
•B 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 HIE will be assessed by Thompson encephalopathy score, and modified Sarnat score.
•C At least 30 minutes duration of amplitude integrated EEG (aEEG) recording that shows moderately abnormal or suppressed background aEEG activity or seizures.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

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

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