NEUROlogical Prognosis After Cardiac Arrest in Kids

Cardiac Arrest Clinical Trial

— NEUROPACK  

Official title:

An Observational Study of Neurodevelopmental Outcome After Cardiac Arrest in Children Admitted to Paediatric Intensive Care in the United Kingdom and Ireland

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03574025
• Other study ID #: NEUROPACK study protocol
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: August 2019

Study information

• Verified date: June 2018
• Source: University of Birmingham
• Contact: Barney Scholefield
• Phone: 0121 333 9684
• Email: bwc.neuropack[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Other:
• Questionnaire
To telephone the patient/family to look into how the patient is doing, moderate/severe brain damage.

Locations

Country	Name	City	State
United Kingdom	Birmingham Women and Children's Hospital PICU	Birmingham	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival with good neurodevelopmental outcome assessed using the Vineland Adaptive Behavioral Score 2nd Edition (VABS-II).	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.	3 months after date of cardiac arrest
Secondary	Neurodevelopmental outcome assessed using the Pediatric Cerebral Performance and Category (PCPC) and Pediatric Overall Performance Category Scale (POPC)	Pediatric Cerebral Performance Category (PCPC) measures cognitive impairment after child's critical illness. Scale 1 to 6 (1 Normal, 2 Mild disability, 3, Moderate disability, 4, Severe disability, 5 Coma/vegetative state, 6, Brain death/death). Pediatric Overall Performance Category Scale (POPC).assesses functional morbidity. Scale 1 to 6 (1 Good overall performance, 2 Mild overall disability, 3 Moderate overall disability, 4 Severe overall disability, 5 Coma or vegetative state, 6 Brain death/death).	3 months after date of cardiac arrest