Cardiac Arrest Clinical Trial
Official title:
An Observational Study of Neurodevelopmental Outcome After Cardiac Arrest in Children Admitted to Paediatric Intensive Care in the United Kingdom and Ireland
Each year around 2000 children have a cardiac arrest in the United Kingdom (UK) and
approximately one fifth are admitted to Pediatric Intensive Care Unit. Many of these children
eventually die and among those who survive, some will be left with brain damage which could
affect their quality of life. Currently, it is difficult for doctors to predict how much
brain damage there is at an early stage after cardiac arrest and if this will improve in
time.
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.
Patients will be recruited from participating PICU's. There is currently lack of accurate
data to enable clinicians to predict which of these children die or survive with brain
injury. This affects clear communication with families as well as decisions to apply critical
care interventions by clinicians. There is also an important knowledge gap with regards to
outcome of children who are admitted to pediatric intensive care after a cardiac arrest and
then survive to discharge.
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.
;
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