Pediatric Resuscitation Neuroprognostication and Outcomes Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 7
- 主要终点
- Long-term Neurological Outcome (PCPC)
研究概览
简要总结
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
详细描述
The PROGNOSE study (Pediatric Resuscitation Neuroprognostication and Outcomes Registry) is a prospective, multicenter, observational patient registry established to improve understanding of short- and long-term outcomes following pediatric cardiac arrest (CA) in the Netherlands. The study focuses on both out-of-hospital (OHCA) and in-hospital cardiac arrest (IHCA) in children under 18 years of age.
Given the rarity yet severity of pediatric CA, the registry aims to collect a large dataset to identify patterns in care, outcomes, and recovery trajectories to ultimately improve treatment strategies and prognosis. The study is considered non-WMO (not subject to the Dutch Medical Research Involving Human Subjects Act), as it involves no additional interventions beyond standard clinical care.
Registry Objectives and Scope The primary objective is to evaluate diagnostic practices and long-term functional and neuropsychological outcomes in pediatric patients post-cardiac arrest. Key secondary objectives include determining the incidence and etiology of pediatric CA in the Netherlands, analyzing survival to discharge, and characterizing post-Return of Circulation (ROC) care.
Data will be collected longitudinally during standard outpatient follow-up visits at specified intervals (3, 12, and 24 months post-arrest; and at the ages of 5, 8, 12, and 17 years, depending on the age at CA event). No study-specific interventions will be performed.
Data Collection and Source Verification
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 24 Hours 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Cardiac arrest occurring in neonates younger than 24 hours of age
- •Cardiac arrest occurring in a neonatal intensive care unit (NICU) setting
结局指标
主要结局
Long-term Neurological Outcome (PCPC)
时间窗: At 3, 12, and 24 months post-cardiac arrest; and at ages 8, 12, and 17 years, depending on age at event
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.
Long-term Neurological Outcome (POPC)
时间窗: At 3, 12, and 24 months post-cardiac arrest; and at ages 8, 12, and 17 years, depending on age at event
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.
Long-term Neurological Outcome (FSS)
时间窗: At 3, 12, and 24 months post-cardiac arrest; and at ages 8, 12, and 17 years, depending on age at event
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.
Neuropsychological Functioning in Pediatric Survivors (composite IQ)
时间窗: At 12 and 24 months after cardiac arrest
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 (%)
Neuropsychological Functioning in Pediatric Survivors (BRIEF-2 or BRIEF-P)
时间窗: At 12 and 24 months after cardiac arrest
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 (%)
Neuropsychological Functioning in Pediatric Survivors (CBCL)
时间窗: At 12 and 24 months after cardiac arrest
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 (%)
Neuropsychological Functioning in Pediatric Survivors (PedsQL)
时间窗: At 12 and 24 months after cardiac arrest
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 (%)
次要结局
- 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)
- In-Hospital Mortality(During initial hospital admission following cardiac arrest)
- Brain Magnetic Resonance Imaging (MRI) Findings(During initial hospital admission following cardiac arrest. Within 7 days after cardiac arrest.)
- Electroencephalography (EEG) Background Assessment(At 24 hours after return of circulation following cardiac arrest.)
- Blood Biomarker Analysis(Within the first 72 hours after cardiac arrest)
- Family/Caregiver Outcomes PedsQL-FIM(At 3, 12, and 24 months after the cardiac arrest event)
- Family/Caregiver Outcomes HADS(At 3, 12, and 24 months after the cardiac arrest event)
研究者
Matthijs de Hoog
Prof. dr.
Erasmus Medical Center