BMJ open · 2026
Paediatric Resuscitation Outcome in Children with Heart Disease (ProCHD): protocol of a Germany-wide multicentre, prospective open registry.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Markel Franziska, Kramer Peter, Anand Jeanine, Heimberg Ellen, Herbsleb Victoria, Amann Valérie, Herberg Ulrike, von Borell du Vernay Florian, Seidemann Kathrin, Liem Lucy, Michaelis Anna, Schmitt Katharina, Weidenbach Michael
Аннотация
INTRODUCTION: While paediatric cardiac arrest is a rare event, consequences for the patients are significant with a considerable risk of morbidity, disability and mortality. The risk of cardiac arrest is substantially increased in children with congenital heart disease. Nevertheless, there is a lack of data concerning this population. To close this knowledge gap, this multicentre, prospective, open registry aims to implement a standardised structure for data collection and follow-up of paediatric cardiac arrests associated with heart diseases in Germany.
METHODS AND ANALYSIS: All paediatric patients who experience a cardiac arrest and receive at least 2 minutes of cardiopulmonary resuscitation are invited to participate in this registry. The dataset comprises demographical, clinical, resuscitation and outcome data, collected in accordance with the Utstein guidelines. Neurological assessments, cognitive and motor tests are conducted at fixed intervals. Additionally, patient-reported outcome measures will be surveyed. Primary outcomes are survival to discharge and neurodevelopmental outcome after discharge and 2 years. The data are pseudonymised prior to submission to an online REDCap database, which is centrally hosted on a server located in Leipzig, Germany.
ETHICS AND DISSEMINATION: This study follows the Declaration of Helsinki and received ethical approval from the Ethics Committee in Leipzig. Registry results will allow us to understand the epidemiology, guideline adherence, risk factors and will be presented at conferences and submitted to a peer-reviewed journal for publication.
TRIAL REGISTRATION NUMBER: NCT05373498.
METHODS AND ANALYSIS: All paediatric patients who experience a cardiac arrest and receive at least 2 minutes of cardiopulmonary resuscitation are invited to participate in this registry. The dataset comprises demographical, clinical, resuscitation and outcome data, collected in accordance with the Utstein guidelines. Neurological assessments, cognitive and motor tests are conducted at fixed intervals. Additionally, patient-reported outcome measures will be surveyed. Primary outcomes are survival to discharge and neurodevelopmental outcome after discharge and 2 years. The data are pseudonymised prior to submission to an online REDCap database, which is centrally hosted on a server located in Leipzig, Germany.
ETHICS AND DISSEMINATION: This study follows the Declaration of Helsinki and received ethical approval from the Ethics Committee in Leipzig. Registry results will allow us to understand the epidemiology, guideline adherence, risk factors and will be presented at conferences and submitted to a peer-reviewed journal for publication.
TRIAL REGISTRATION NUMBER: NCT05373498.