Dutch Registry of Pediatric Cardiac Arrest
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age24-18
SponsorMatthijs de Hoog
About this trial
The goal of this observational study is to understand the long-term outcomes of children in the Netherlands who experience cardiac arrest, either in or outside of the hospital. The main questions it aims to answer are:
What are the survival rates and neurological outcomes in children after cardiac arrest?
What types of emergency and post-resuscitation care are provided, and how do they impact long-term recovery?
How do children and their families function over time after the event?
Researchers will analyze data from routine medical records and follow patients through standard outpatient visits. No extra procedures will be required beyond normal care. For those who survive to hospital discharge, additional follow-up data will be collected with consent.
Participants will:
Be children under 18 years old who have had a cardiac arrest and were treated in one of the seven participating academic hospitals
Have their routine medical care data collected anonymously
Be invited (if surviving) for follow-up visits at 3, 12, and 24 months post-arrest and at specific ages (5, 8, 12, and 17 years) to assess physical and psychological recovery
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pediatric patients under the age of 18
Experienced in-hospital or out-of-hospital cardiac arrest in the Netherlands
Attended by emergency medical services or admitted to one of the seven participating Dutch academic pediatric hospitals
Cardiac arrest defined as absence of palpable pulse or need for chest compressions lasting ≥1 minute
Disqualifiers
Cardiac arrest occurring in neonates younger than 24 hours of age
Cardiac arrest occurring in a neonatal intensive care unit (NICU) setting
Trial population
Pediatric patients under 18 years of age who experienced a cardiac arrest, either in-hospital or out-of-hospital, in the Netherlands. Eligible patients must have received chest compressions for at least one minute and been treated by emergency medical services or admitted to one of seven participating Dutch academic pediatric hospitals. Neonates under 24 hours old and NICU arrests are excluded.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: Pediatric cardiac arrest patient
Trial outcomes
Primary outcomes
1
Long-term Neurological Outcome (PCPC)
Neurological outcome will be assessed using the Pediatric Cerebral Performance Category (PCPC) scale, a validated functional outcome measure ranging from 1 to 6. A score of 1 indicates normal age-appropriate cerebral performance, while higher scores reflect increasing levels of neurological impairment: mild (2), moderate (3), severe (4), coma or vegetative state (5), and death (6). Lower scores indicate better neurological function. The highest available follow-up score will be used as the primary neurological outcome measure.
Time frame
At 3, 12, and 24 months post-cardiac arrest; and at ages 8, 12, and 17 years, depending on age at event2
Long-term Neurological Outcome (POPC)
Overall functional outcome will be assessed using the Pediatric Overall Performance Category (POPC) scale, a validated tool measuring global functional status in children following critical illness or injury. Scores range from 1 (normal) to 6 (death), with higher scores indicating greater overall disability. POPC complements the PCPC by evaluating broader aspects of daily functioning.
Time frame
At 3, 12, and 24 months post-cardiac arrest; and at ages 8, 12, and 17 years, depending on age at event3
Long-term Neurological Outcome (FSS)
Functional outcome will also be measured using the Functional Status Scale (FSS), a detailed, domain-specific assessment covering six areas: mental status, sensory, communication, motor function, feeding, and respiratory status. Each domain is scored from 1 (normal) to 5 (very severe dysfunction), with a total score ranging from 6 to 30. Lower total scores indicate better overall function.
Time frame
At 3, 12, and 24 months post-cardiac arrest; and at ages 8, 12, and 17 years, depending on age at event4
Neuropsychological Functioning in Pediatric Survivors (composite IQ)
Neuropsychological outcomes will be assessed using standardized, age-appropriate cognitive and behavioral tests administered during follow-up. The assessment includes: Wechsler Intelligence Scale for Children (WISC-V) or Bayley Scales of Infant Development (Bayley-III) depending on age: Composite IQ or developmental index (range varies by age, mean = 100, SD = 15). Unit of Measure: Standardized test scores (mean ± SD) and proportion of patients with clinically significant impairment (%)
Time frame
At 12 and 24 months after cardiac arrestSecondary outcomes
1
Incidence and Cause of Cardiac Arrest
Differentiated by IHCA and OHCA First documented rhythm and suspected etiology
Time frame
At the time of in-hospital or out-of-hospital cardiac arrest, during initial hospital evaluation2
Pre-hospital Interventions Performed (Composite)
This is a composite outcome measure indicating whether any of the following pre-hospital interventions were performed during the cardiac arrest event: Bystander-performed basic life support (BLS) Use of an automated external defibrillator (AED) Initiation of extracorporeal cardiopulmonary resuscitation (ECPR) The presence of any one or more of these interventions will qualify as a positive occurrence for the composite measure. Unit of Measure: Proportion of patients (%) who received at least one of the listed interventions. Presentation: All components of the composite measure will be presented together in a single summary table.
Time frame
At time of cardiac arrest event, as documented during emergency response and initial hospital admission3
Duration of Cardiopulmonary Resuscitation (CPR)
The total duration, in minutes, of cardiopulmonary resuscitation performed during the cardiac arrest event. This includes both basic and advanced life support provided by bystanders and emergency medical services prior to return of spontaneous circulation or termination of resuscitation efforts.Unit of Measure: Minutes
Time frame
At the time of the cardiac arrest event, as documented during emergency medical response and initial hospital admission.4
Return of Circulation (ROC)
Whether return of spontaneous circulation was achieved following cardiac arrest, as documented by clinical and physiological parameters. Unit of Measure: Proportion of patients (%)
Time frame
Time Frame: During initial hospital admission following cardiac arrestSponsors and contacts
Click on the lead sponsor to view all of their trials.
Matthijs de Hoog
Lead sponsor
Erasmus Medical Center
Sponsor institution
Amsterdam UMC
Collaborator
Radboud University Medical Center
Collaborator
University Medical Center Groningen
Collaborator
Maastricht University Medical Center
Collaborator
UMC Utrecht
Collaborator
Zoll Medical Corporation
Collaborator
Stichting Vermeer14
Collaborator
Leiden University Medical Center
Collaborator
Source ClinicalTrials.gov