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NEUROlogical Prognosis After Cardiac Arrest in Kids (NEUROPACK)

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ClinicalTrials.gov Identifier: NCT03574025
Recruitment Status : Recruiting
First Posted : June 29, 2018
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
University of Birmingham

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.


Condition or disease Intervention/treatment
Cardiac Arrest Other: Questionnaire

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:

  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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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: An Observational Study of Neurodevelopmental Outcome After Cardiac Arrest in Children Admitted to Paediatric Intensive Care in the United Kingdom and Ireland
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Group/Cohort Intervention/treatment
Cardiac Arrest Questionnaire
Children who will survive 3 months after Cardiac Arrest
Other: Questionnaire
To telephone the patient/family to look into how the patient is doing, moderate/severe brain damage.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Neurodevelopmental outcome assessed using the Pediatric Cerebral Performance and Category (PCPC) and Pediatric Overall Performance Category Scale (POPC) [ Time Frame: 3 months after date of cardiac arrest ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03574025


Contacts
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Contact: Barney Scholefield 0121 333 9684 bwc.neuropack@nhs.net
Contact: Kate Penny-Thomas 0121 333 9684 bwc.neuropack@nhs.net

Locations
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United Kingdom
Birmingham Women and Children's Hospital PICU Recruiting
Birmingham, West Midlands, United Kingdom, B4 6NH
Contact: Barney Scholefield    0121 3339684    bwc.neuropack@nhs.net   
Sponsors and Collaborators
University of Birmingham
Investigators
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Study Chair: Barney Scholefield Birmingham Women's and Children's Hospital

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Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT03574025     History of Changes
Other Study ID Numbers: NEUROPACK study protocol
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: there is no plan to share individual participant data, however, we will be using and sharing data collected as a whole to construct a prediction tool to help clinicians predict the level of brain damage after cardiac arrest occurs.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Birmingham:
Observational, Paediatric, Cardiac Arrest, PICU,

Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases