NEUROlogical Prognosis After Cardiac Arrest in Kids (NEUROPACK) study : protocol for a prospective multicentre clinical prediction model derivation and validation study in children after cardiac arrest
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ..
INTRODUCTION: Currently, we are unable to accurately predict mortality or neurological morbidity following resuscitation after paediatric out of hospital (OHCA) or in-hospital (IHCA) cardiac arrest. A clinical prediction model may improve communication with parents and families and risk stratification of patients for appropriate postcardiac arrest care. This study aims to the derive and validate a clinical prediction model to predict, within 1 hour of admission to the paediatric intensive care unit (PICU), neurodevelopmental outcome at 3 months after paediatric cardiac arrest.
METHODS AND ANALYSIS: A prospective study of children (age: >24 hours and <16 years), admitted to 1 of the 24 participating PICUs in the UK and Ireland, following an OHCA or IHCA. Patients are included if requiring more than 1 min of cardiopulmonary resuscitation and mechanical ventilation at PICU admission Children who had cardiac arrests in PICU or neonatal intensive care unit will be excluded. Candidate variables will be identified from data submitted to the Paediatric Intensive Care Audit Network registry. Primary outcome is neurodevelopmental status, assessed at 3 months by telephone interview using the Vineland Adaptive Behavioural Score II questionnaire. A clinical prediction model will be derived using logistic regression with model performance and accuracy assessment. External validation will be performed using the Therapeutic Hypothermia After Paediatric Cardiac Arrest trial dataset. We aim to identify 370 patients, with successful consent and follow-up of 150 patients. Patient inclusion started 1 January 2018 and inclusion will continue over 18 months.
ETHICS AND DISSEMINATION: Ethical review of this protocol was completed by 27 September 2017 at the Wales Research Ethics Committee 5, 17/WA/0306. The results of this study will be published in peer-reviewed journals and presented in conferences.
TRIAL REGISTRATION NUMBER: NCT03574025.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:10 |
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| Enthalten in: |
BMJ open - 10(2020), 9 vom: 25. Sept., Seite e037517 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Scholefield, Barnaby Robert [VerfasserIn] |
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| Links: |
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| Themen: |
Journal Article |
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| Anmerkungen: |
Date Completed 14.05.2021 Date Revised 14.05.2021 published: Electronic ClinicalTrials.gov: NCT03574025 Citation Status MEDLINE |
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| doi: |
10.1136/bmjopen-2020-037517 |
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| funding: |
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| PPN (Katalog-ID): |
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| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03574025 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. | ||
| 520 | |a INTRODUCTION: Currently, we are unable to accurately predict mortality or neurological morbidity following resuscitation after paediatric out of hospital (OHCA) or in-hospital (IHCA) cardiac arrest. A clinical prediction model may improve communication with parents and families and risk stratification of patients for appropriate postcardiac arrest care. This study aims to the derive and validate a clinical prediction model to predict, within 1 hour of admission to the paediatric intensive care unit (PICU), neurodevelopmental outcome at 3 months after paediatric cardiac arrest | ||
| 520 | |a METHODS AND ANALYSIS: A prospective study of children (age: >24 hours and <16 years), admitted to 1 of the 24 participating PICUs in the UK and Ireland, following an OHCA or IHCA. Patients are included if requiring more than 1 min of cardiopulmonary resuscitation and mechanical ventilation at PICU admission Children who had cardiac arrests in PICU or neonatal intensive care unit will be excluded. Candidate variables will be identified from data submitted to the Paediatric Intensive Care Audit Network registry. Primary outcome is neurodevelopmental status, assessed at 3 months by telephone interview using the Vineland Adaptive Behavioural Score II questionnaire. A clinical prediction model will be derived using logistic regression with model performance and accuracy assessment. External validation will be performed using the Therapeutic Hypothermia After Paediatric Cardiac Arrest trial dataset. We aim to identify 370 patients, with successful consent and follow-up of 150 patients. Patient inclusion started 1 January 2018 and inclusion will continue over 18 months | ||
| 520 | |a ETHICS AND DISSEMINATION: Ethical review of this protocol was completed by 27 September 2017 at the Wales Research Ethics Committee 5, 17/WA/0306. The results of this study will be published in peer-reviewed journals and presented in conferences | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT03574025 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a paediatric intensive & critical care | |
| 650 | 4 | |a protocols & guidelines | |
| 700 | 1 | |a Martin, James |e verfasserin |4 aut | |
| 700 | 1 | |a Penny-Thomas, Kate |e verfasserin |4 aut | |
| 700 | 1 | |a Evans, Sarah |e verfasserin |4 aut | |
| 700 | 1 | |a Kool, Mirjam |e verfasserin |4 aut | |
| 700 | 1 | |a Parslow, Roger |e verfasserin |4 aut | |
| 700 | 1 | |a Feltbower, Richard |e verfasserin |4 aut | |
| 700 | 1 | |a Draper, Elizabeth S |e verfasserin |4 aut | |
| 700 | 1 | |a Hiley, Victoria |e verfasserin |4 aut | |
| 700 | 1 | |a Sitch, Alice J |e verfasserin |4 aut | |
| 700 | 1 | |a Kanthimathinathan, Hari Krishnan |e verfasserin |4 aut | |
| 700 | 1 | |a Morris, Kevin P |e verfasserin |4 aut | |
| 700 | 1 | |a Smith, Fang |e verfasserin |4 aut | |
| 700 | 0 | |a NEUROPACK Investigators for the Paediatric Intensive Care Society-Study Group (PICS-SG) |e verfasserin |4 aut | |
| 700 | 1 | |a Thorburn, Kent |e investigator |4 oth | |
| 700 | 1 | |a Saxena, Rohit |e investigator |4 oth | |
| 700 | 1 | |a Thiru, Yamuna |e investigator |4 oth | |
| 700 | 1 | |a Levin, Richard |e investigator |4 oth | |
| 700 | 1 | |a Agbecko, Rachel |e investigator |4 oth | |
| 700 | 1 | |a Thiruchelvam, Timothy |e investigator |4 oth | |
| 700 | 1 | |a Skellett, Sophie |e investigator |4 oth | |
| 700 | 1 | |a Inwald, David |e investigator |4 oth | |
| 700 | 1 | |a Weitz, James |e investigator |4 oth | |
| 700 | 1 | |a Deep, Akash |e investigator |4 oth | |
| 700 | 1 | |a Cooper, Sian |e investigator |4 oth | |
| 700 | 1 | |a Barry, Peter |e investigator |4 oth | |
| 700 | 1 | |a Davies, Patrick |e investigator |4 oth | |
| 700 | 1 | |a Breatnach, Cormac |e investigator |4 oth | |
| 700 | 1 | |a Gala-Peralta, Sandra |e investigator |4 oth | |
| 700 | 1 | |a Lo, Milly |e investigator |4 oth | |
| 700 | 1 | |a Barber, Rachael |e investigator |4 oth | |
| 700 | 1 | |a Reid, Stewart |e investigator |4 oth | |
| 700 | 1 | |a Thomas, Rum |e investigator |4 oth | |
| 700 | 1 | |a Pappachan, John |e investigator |4 oth | |
| 700 | 1 | |a Dwarakanathan, Buvana |e investigator |4 oth | |
| 700 | 1 | |a Oruganti, Siva |e investigator |4 oth | |
| 700 | 1 | |a Sadasivam, Kalai |e investigator |4 oth | |
| 700 | 1 | |a Bebbington, Mark |e investigator |4 oth | |
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