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

Not Applicable

Completed

• Conditions: Children with a congenital heart defect which results in cyanosis and which are amenable to surgical repair; Surgery; Congenital malformations of cardiac chambers and connections

• Registration Number: ISRCTN81773762
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust

Brief Summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19577081

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-07-10
• Study Completion: 2015-06-05
• Last Update Posted: 9 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified