The EPIgenetic consequences in children of Volatile-based anaesthesia and surgery, with high or low OXygen exposure (EPI-VOX) – A single centre, double-blinded, randomised, feasibility trial

niversity Hospital Southampton NHS Foundation Trust0 个研究点目标入组 10 人开始时间: 2023年5月22日最近更新: 2023年10月3日

适应症

试验速览

暂无简介。

•1. Age =6 months and =3 years at time of initial operation
•2. Undergoing surgical management of DDH (unilateral or bilateral)
•3. Completed informed consent form (ICF) from legal representative (LR (this is the person who is empowered to give informed consent on behalf of a participant. For most children this will be one or both parents. This may also be a guardian or custodian with legal custody)).

•1. Legal representative (LR) unable to provide completed ICF
•2. Withdrawal of consent at any stage
•3. Previous exposure to general anaesthesia at any stage of life, including in-utero (through maternal exposure at any stage until delivery)
•4. Neurodevelopmental/neurodisability diagnosis (given or under investigation) from a paediatric service including autistic spectrum disorder (ASD), attention deficit disorder (ADHD), traumatic brain injury (TBI), down’s syndrome, cerebral palsy, epilepsy
•5. Chronic respiratory diagnosis (given or under investigation) from a paedatric service, including bronchopulmonary dysplasia and cystic fibrosis with pulmonary manifestations, but excluding asthma
•6. Clinical opinion that randomising the child’s oxygen exposure would be unsafe
•7. Clinical opinion that the use of a volatile anaesthesic agent would be unsafe

发起方

niversity Hospital Southampton NHS Foundation Trust