A multicentre randomised controlled trial comparing regional and general anaesthesia for effects on neurodevelopmental outcome and apnoea in infants

HS Greater Glasgow and Clyde and University of Glasgow (UK)0 个研究点目标入组 660 人开始时间: 2009年6月3日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1. Any infant scheduled for unilateral or bilateral inguinal hernia repair (with or without circumcision)
•2. Any infant whose gestational age (GA) is 26 weeks or more (GA = 182 days)
•3. Any infant whose post-menstrual age (PMA) is up to 60 weeks (PMA = 426 days)
•Minimum age: 26 weeks
•Maximum age: 60 weeks
•Gender: both males and females

•1. Any child older than 60 weeks post-menstrual age
•2. Any child born at less than 26 weeks gestation
•3. Any contraindication to general or spinal/caudal anaesthesia (for example: neuromuscular disorder or coagulopathy)
•4. Pre-operative ventilation immediately prior to surgery
•5. Congenital heart disease that has required surgery or will require surgery or which requires ongoing pharmacotherapy
•6. Known chromosomal abnormality or any other known acquired or congenital abnormalities (apart from prematurity) which are likely to affect development
•7. Children where follow-up would be difficult for geographic or social reasons
•8. Families where English (or French for Paris and Montreal sites) is not the language spoken at home
•9. Known neurological injury such as cystic periventricular leukomalacia (PVL), or grade 3 or 4 intra-ventricular haemorrhage (IVH) (+/- post-haemorrhage ventricular dilatation)
•10. Previous exposure to volatile anaesthesia or benzodiazepines as a neonate or in the third trimester in utero

发起方

HS Greater Glasgow and Clyde and University of Glasgow (UK)