An Observational Study of Neurodevelopmental Outcome After Cardiac Arrest in Children Admitted to Paediatric Intensive Care in the United Kingdom and Ireland
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Birmingham
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Survival with good neurodevelopmental outcome assessed using the Vineland Adaptive Behavioral Score 2nd Edition (VABS-II).
Study Overview
Brief Summary
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.
Detailed Description
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:
- Patients aged 24 hours up to 16th birthday
- Requiring > 1minute cardiopulmonary resuscitation
- Admitted to PICU after Out of Hospital Cardiac Arrest or In Hospital Cardiac Arrest
- Requiring mechanical ventilation at PICU admission
- Surviving to 3 months follow up.
Exclusion criteria:
- Cardiac arrest occurring within a PICU or NICU (Neonatal Intensive Care Unit)
- Clinical team at participating sites feel inclusion is inappropriate
- Parent/ guardian or family member unable to understand the telephone questionnaires for outcome assessments in English
Study Design
- Study Type
- Observational
- Observational Model
- Family Based
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 24 Hours to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 24 hours up to 16th birthday
- •Requiring > 1minute cardiopulmonary resuscitation
- •Admitted to PICU after Out of Hospital Cardiac Arrest or In Hospital Cardiac Arrest
- •Requiring mechanical ventilation at PICU admission
- •Surviving to 3 months follow up.
Exclusion Criteria
- •Cardiac arrest occurring within a PICU or NICU (Neonatal Intensive Care Unit)
- •Clinical team at participating sites feel inclusion is inappropriate
- •Parent/ guardian or family member unable to understand the telephone questionnaires for outcome assessments in English
Outcomes
Primary Outcomes
Survival with good neurodevelopmental outcome assessed using the Vineland Adaptive Behavioral Score 2nd Edition (VABS-II).
Time Frame: 3 months after date of cardiac arrest
The VABS-II is a measure of adaptive behavior validated from birth to adulthood. VABS-II standardized score \> 70 is pre-defined as a 'Good outcome'. A score of 70 or less and death is a 'Poor outcome'. The VABS-II outcome score will be used to create a clinical prediction model of neurodevelopmental outcome within one hour of admission to pediatric intensive care for future reference that clinicians can use to predict which children with cardiac arrest may survive with minimal brain damage.
Secondary Outcomes
- Neurodevelopmental outcome assessed using the Pediatric Cerebral Performance and Category (PCPC) and Pediatric Overall Performance Category Scale (POPC)(3 months after date of cardiac arrest)