Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2018-01-01
2019-08-31
Brief Summary
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NEURO-PACK aims to follow up children 3 months after their cardiac arrest to assess their quality of life and current functional status (has the child returned to usual routine as before cardiac arrest/mild disability, can the child not participate in certain activities as they were before the cardiac arrest/moderate disability, or if the child has near to no mobility/severe disability). Investigators will find this out by using a questionnaire and the research team will telephone patients and their families 3 months after the child's cardiac arrest. This telephone call should take no longer than 30 minutes. This will then be analysed and will help towards constructing a tool which will help doctors to predict which children who have had a cardiac arrest may survive with minimal brain damage.
Detailed Description
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Inclusion Criteria:
1. Patients aged 24 hours up to 16th birthday
2. Requiring \> 1minute cardiopulmonary resuscitation
3. Admitted to PICU after Out of Hospital Cardiac Arrest or In Hospital Cardiac Arrest
4. Requiring mechanical ventilation at PICU admission
5. Surviving to 3 months follow up.
Exclusion criteria:
1. Cardiac arrest occurring within a PICU or NICU (Neonatal Intensive Care Unit)
2. Clinical team at participating sites feel inclusion is inappropriate
3. Parent/ guardian or family member unable to understand the telephone questionnaires for outcome assessments in English
The NEURO-PACK observational study enables the prospective collection of a cohort of children after out-of-hospital or in-hospital cardiac arrest. Data will be collected prospectively after eligible patients are screened and informed consent has been obtained. Participants and their families will be contacted by the Trials office,3 months after the patients cardiac arrest to complete a questionnaire over the telephone regarding functional status. Only contact information of the parents/guardians will be shared with the central Trials Office once informed consent has been obtained so that follow-up assessments can be completed. This information will be stored in locked cabinets, in a swipe card Trials Office based in Birmingham for five years, in line with Good Clinical Practice (GCP) guidance.
The information collected from patients and their families will be analyzed and used to help construct a clinical prediction tool which will help clinicians to predict which children who have had cardiac arrest may survive with minimal brain damage.
Conditions
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Keywords
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Study Design
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FAMILY_BASED
PROSPECTIVE
Study Groups
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Cardiac Arrest Questionnaire
Children who will survive 3 months after Cardiac Arrest
Questionnaire
To telephone the patient/family to look into how the patient is doing, moderate/severe brain damage.
Interventions
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Questionnaire
To telephone the patient/family to look into how the patient is doing, moderate/severe brain damage.
Eligibility Criteria
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Inclusion Criteria
2. Requiring \> 1minute cardiopulmonary resuscitation
3. Admitted to PICU after Out of Hospital Cardiac Arrest or In Hospital Cardiac Arrest
4. Requiring mechanical ventilation at PICU admission
5. Surviving to 3 months follow up.
Exclusion Criteria
2. Clinical team at participating sites feel inclusion is inappropriate
3. Parent/ guardian or family member unable to understand the telephone questionnaires for outcome assessments in English
24 Hours
16 Years
ALL
No
Sponsors
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University of Birmingham
OTHER
Responsible Party
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Principal Investigators
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Barney Scholefield
Role: STUDY_CHAIR
Birmingham Women's and Children's Hospital
Locations
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Birmingham Women and Children's Hospital PICU
Birmingham, West Midlands, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Barney Scholefield
Role: primary
References
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Scholefield BR, Martin J, Penny-Thomas K, Evans S, Kool M, Parslow R, Feltbower R, Draper ES, Hiley V, Sitch AJ, Kanthimathinathan HK, Morris KP, Smith F; NEUROPACK Investigators for the Paediatric Intensive Care Society-Study Group (PICS-SG). 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. BMJ Open. 2020 Sep 25;10(9):e037517. doi: 10.1136/bmjopen-2020-037517.
Other Identifiers
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NEUROPACK study protocol
Identifier Type: -
Identifier Source: org_study_id