Dutch Registry of Pediatric Cardiac Arrest

NCT06938009 | Recruiting

• 1 other identifier: MEC-2023-0133
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Cardiac Arrest (CA); Pediatric ALL

Keywords

Pediatric cardiac arrest; Neuroprognostication; Long-term outcomes; Observational registry

Outcome Measures

Primary Outcomes (7)

• 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.

  At 3, 12, and 24 months post-cardiac arrest; and at ages 8, 12, and 17 years, depending on age at event

• 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.

  At 3, 12, and 24 months post-cardiac arrest; and at ages 8, 12, and 17 years, depending on age at event

• 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.

  At 3, 12, and 24 months post-cardiac arrest; and at ages 8, 12, and 17 years, depending on age at event

• 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 (%)

  At 12 and 24 months after cardiac arrest

• Neuropsychological Functioning in Pediatric Survivors (BRIEF-2 or BRIEF-P)

  Neuropsychological outcomes will be assessed using standardized, age-appropriate cognitive and behavioral tests administered during follow-up. The assessment includes: Behavior Rating Inventory of Executive Function (BRIEF-2 or BRIEF-P): T-scores, where higher scores indicate more executive dysfunction (mean = 50, SD = 10). Unit of Measure: Standardized test scores (mean ± SD) and proportion of patients with clinically significant impairment (%)

  At 12 and 24 months after cardiac arrest

• Neuropsychological Functioning in Pediatric Survivors (CBCL)

  Neuropsychological outcomes will be assessed using standardized, age-appropriate cognitive and behavioral tests administered during follow-up. The assessment includes: Child Behavior Checklist (CBCL): Total problem score, higher scores indicate more behavioral/emotional problems (T-score, mean = 50, SD = 10). Unit of Measure: Standardized test scores (mean ± SD) and proportion of patients with clinically significant impairment (%)

  At 12 and 24 months after cardiac arrest

• Neuropsychological Functioning in Pediatric Survivors (PedsQL)

  Neuropsychological outcomes will be assessed using standardized, age-appropriate cognitive and behavioral tests administered during follow-up. The assessment includes: Pediatric Quality of Life Inventory (PedsQL): Total score from 0 to 100; higher scores reflect better quality of life. Unit of Measure: Standardized test scores (mean ± SD) and proportion of patients with clinically significant impairment (%)

  At 12 and 24 months after cardiac arrest

Secondary Outcomes (11)

• Incidence and Cause of Cardiac Arrest

  At the time of in-hospital or out-of-hospital cardiac arrest, during initial hospital evaluation

• Pre-hospital Interventions Performed (Composite)

  At time of cardiac arrest event, as documented during emergency response and initial hospital admission

• Duration of Cardiopulmonary Resuscitation (CPR)

  At the time of the cardiac arrest event, as documented during emergency medical response and initial hospital admission.

• Return of Circulation (ROC)

  Time Frame: During initial hospital admission following cardiac arrest

• Survival to Hospital Discharge

  Time Frame: During initial hospital admission following cardiac arrest

Study Arms (1)

Pediatric cardiac arrest patient

The study cohort consists of pediatric patients under the age of 18 who have experienced a cardiac arrest-either in-hospital (IHCA) or out-of-hospital (OHCA)-in the Netherlands. Eligible patients must have received care from emergency medical services (EMS) or been admitted to one of the seven participating academic pediatric hospitals following the arrest. Cardiac arrest is defined as the absence of a palpable pulse or the need for chest compressions lasting at least one minute, in line with European Resuscitation Council guidelines. Both basic life support (BLS) and advanced pediatric life support (APLS) protocols apply.

Eligibility Criteria

• Age: 24 Hours - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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
• Arrest managed under European Resuscitation Council guidelines (BLS/APLS)

You may not qualify if:

• Cardiac arrest occurring in neonates younger than 24 hours of age
• Cardiac arrest occurring in a neonatal intensive care unit (NICU) setting

Sponsors & Collaborators

• Matthijs de Hoog: lead
• 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

Study Sites (7)

Radboud umc

Nijmegen, Gelderland, 6525 XZ, Netherlands

RECRUITING

MUMC

Maastricht, Limburg, 6229 ET, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

UMCG

Groningen, Provincie Groningen, 9713 GZ, Netherlands

RECRUITING

LUMC

Leiden, South Holland, 2333 ZG, Netherlands

RECRUITING

Erasmus MC

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

UMCU

Utrecht, Utrecht, 3584 CX, Netherlands

RECRUITING

Related Publications (1)

• Albrecht M, Hunfeld M, Arkesteijn-Muit A, Dulfer K, de Hoog M, de Jong G, de Jonge R, Lamore A, Nadkarni V, Buysse C; PROGNOSE Group Collaborative Investigators. A Dutch nationwide pediatric cardiac arrest registry with long-term follow-up - towards an international prognostication guideline. Resusc Plus. 2025 May 9;24:100976. doi: 10.1016/j.resplu.2025.100976. eCollection 2025 Jul.

  PMID: 40491775 DERIVED

MeSH Terms

Conditions

Heart Arrest; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Corinne Buysse, MD PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabry De Jong

CONTACT

0031107040704; gabry.dejong@erasmusmc.nl

Marijn Albrecht, MD

CONTACT

0031107040704; m.albrecht@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 22, 2025
• Study Start: June 14, 2023
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD and supporting documents will become available upon publication of the protocol paper.
• Access Criteria: Access to IPD will be available through the published protocol paper. Researchers may request additional clarification or documentation by contacting the study team. Use of data must be for scientific, non-commercial purposes, and in accordance with ethical and privacy standards.

Locations

NL (7)