Cardiac ArrestNEUROPACKNCT03574025
NEUROlogical Prognosis After Cardiac Arrest in Kids
An observational study of Cardiac Arrest, run by University of Birmingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 24 hours to 16 years
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Questionnaire
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2018to Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 hours to 16 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Birmingham Women and Children's Hospital PICU
Birmingham, West Midlands, B4 6NH
Barney Scholefield, 0121 3339684, bwc.neuropack@nhs.net
About this study
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.
Read the 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
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.
- Conditions
- Cardiac Arrest
- Being tested
- Questionnaire
- Keywords
- Observational, Paediatric, Cardiac Arrest, PICU,
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
To telephone the patient/family to look into how the patient is doing, moderate/severe brain damage.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Arrest Questionnaire | Children who will survive 3 months after Cardiac Arrest Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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).
Measured: 3 months after date of cardiac arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start1 Jan 2018
- Primary completionMay 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barney Scholefield, Study chair, Birmingham Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574025
- Sponsor's protocol ID
- NEUROPACK study protocol
- Acronym
- NEUROPACK
- Status last verified
- Jun 2018
- First submitted
- 30 Oct 2017
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 32978195
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Neurodevelopmental Outcome After Cardiac Arrest in Children Admitted to Paediatric Intensive Care in the United Kingdom and Ireland
- ClinicalTrials.gov ID
- NCT03574025
- Acronym / sponsor ID
- NEUROPACK / NEUROPACK study protocol
- Conditions
- Cardiac Arrest
- Keywords
- Observational, Paediatric, Cardiac Arrest, PICU,
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 29 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Arrest Questionnaire | – | Other: QuestionnaireChildren who will survive 3 months after Cardiac Arrest |
Who may qualify
- Ages
- 24 hours to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireTo telephone the patient/family to look into how the patient is doing, moderate/severe brain damage. | Other | Cardiac Arrest Questionnaire |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Derived from this study: PubMed 32978195Scholefield 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barney Scholefield study chair
Birmingham Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barney Scholefield (0121 333 9684, bwc.neuropack@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03574025, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018.