NEUROlogical Prognosis After Cardiac Arrest in Kids

NCT03574025 | Unknown

• 1 other identifier: NEUROPACK study protocol
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest

Keywords

Observational, Paediatric, Cardiac Arrest, PICU,

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Cardiac Arrest Questionnaire

Children who will survive 3 months after Cardiac Arrest

Other: Questionnaire

Interventions

Questionnaire OTHER

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

Cardiac Arrest Questionnaire

Eligibility Criteria

• Age: 24 Hours - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children aged more than 24 hours and up to their 16th birthday who are admitted to PICU after a cardiac arrest outside of the unit. Patients aged less than 24 hours will not be included as these patients are frequently managed within the neonatal intensive care unit setting. Patients aged 16 years or greater are frequently managed in the UK within the adult intensive care setting. Only patient admitted to a PICU will be eligible.

You may qualify if:

• 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.

You may not qualify if:

• Cardiac arrest occurring within a PICU or NICU (Neonatal Intensive Care Unit)
• Parent/ guardian or family member unable to understand the telephone questionnaires for outcome assessments in English

Sponsors & Collaborators

• University of Birmingham: lead

Study Sites (1)

Birmingham Women and Children's Hospital PICU

Birmingham, West Midlands, B4 6NH, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 32978195 DERIVED

MeSH Terms

Conditions

Heart Arrest

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Barney Scholefield

  Birmingham Women's and Children's Hospital

  STUDY CHAIR

Central Study Contacts

Barney Scholefield

CONTACT

0121 333 9684; bwc.neuropack@nhs.net

Kate Penny-Thomas

CONTACT

0121 333 9684; bwc.neuropack@nhs.net

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: June 29, 2018
• Study Start: January 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: August 1, 2019
• Last Updated: June 29, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)