ISRCTN58025172
进行中（未招募）
4 期
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2023年5月22日
概览
- 阶段
- 4 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Children aged under 3 years old and undergoing general anaesthesia and surgery for developmental dysplasia of the hip.
- 发起方
- niversity Hospital Southampton NHS Foundation Trust
- 入组人数
- 10
- 状态
- 进行中（未招募）
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •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)).
排除标准
- •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
结局指标
主要结局
未指定
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