A randomised controlled trial to compare normoxic versus standard cardiopulmonary bypass in cyanotic children undergoing cardiac surgery

niversity Hospitals Bristol NHS Foundation Trust0 个研究点目标入组 90 人开始时间: 2008年7月10日最近更新: 2019年9月9日

试验速览

•Current inclusion criteria as of 08/03/2013:
•1. Cyanotic children undergoing operations to repair or palliate a heart defect
•2. Children must be =1 month old to be eligible for all the neurocognitive assessments. Children <1 month old are eligible only for the 3 and 12 month post-operative neurocognitive assessments
•Previous inclusion criteria until 08/03/2013:
•1. Cyanotic children undergoing operations to repair or palliate a heart defect
•2. Children aged >= 1 month of age
•Previous inclusion criteria until 26/07/2012:
•1. Cyanotic children (both males and females) undergoing operations to repair a heart defect
•2. Children aged >= 1 month of age

•Current exclusion criteria as of 08/03/2013:
•1. Children with a preoperative diagnosis of Down?s syndrome or other developmental disorders are excluded from the neurocognitive assessments as part of the trial, but may be included in the main study
•2. Emergency operations
•3. Children requiring cardiovascular and/or respiratory support prior to study entry
•Previous exclusion criteria until 08/03/2013:
•1. Children with a preoperative diagnosis of Down's syndrome or other developmental disorders are excluded from the neurocognitive assessments as part of the trial, but may be included in the main study
•2. Emergency operations
•3. Patients undergoing arterial switch procedure
•4. Neonatal patients (<1 month old)
•Previous exclusion criteria as of 26/07/2012:
•1. Preoperative diagnosis of Down's syndrome or other developmental disorders

发起方

niversity Hospitals Bristol NHS Foundation Trust