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Набор скоро начнётся NCT06124092

Outcomes of Children After Hospitalization in Intensive Care Unit

— Наблюдательное Renal Disease Liver Diseases Heart Diseases Trauma Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: neurocognitive tests.
Кому может быть актуально
Состояния в реестре: Renal Disease, Liver Diseases, Heart Diseases, Trauma Injury. Базовые параметры: до 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

After Pediatric Critical Illness (APCI)

Обзор

More than 10,000 children are hospitalized in an PICU every year in Canada. While most of them will survive their PICU hospitalization and their critical illness, some children will not recover to their pre-illness level. Some may develop behavioral, physical, emotional or developmental problems and difficulties at school. All these problems are elements that are part of the Pediatric Post-Intensive Care Syndrome (PICS-p). It is important to understand the elements (risk factors) that play a role in the development of PICS-p. In Canada, there is no systematic follow-up for children after they leave the PICU. Understanding what can cause PICS-p (risk factors) and how much PICS-p has an impact on children and their family is very important to the family well-being.

Подробное описание

The Pediatric Post-Intensive Care Syndrome (PICS-p) is a newly developed conceptual framework that incorporates the constellation of morbidities that are increasingly recognized to affect children and their families after a critical illness. Experts define PICS-p as a new or worsening impairment in any of the following 5 domains of child health: physical, cognitive, emotional, social, or family.

In contrast to well established follow-up programs in adults, there is currently a lack of systematic follow-up of PICU survivors which prevents both the recognition and management of PICS-p. The absence of granular, empirical data on the recovery of PICU children impedes both the identification and management of PICS-p.

This project is a prospective Canadian multicenter cohort study to identify risk factors of PICS-p, develop and validate a predictive model for PICS-p to detect at-risk children, characterize each domain of PICS-p over two years post critical illness and uncover additional morbidities that are not captured using the current PICS-p framework. This study will provide granular, empirical data on which to build developmentally appropriate and tailored screening, management, and intervention programs during and after PICU to improve the global recovery of critically ill children and their family.

Вмешательства

  • Другое neurocognitive tests
    Cohort study: all parents and participants will have questionnaires to complete, based on participant's age.

Первичные конечные точки

  • Identify risk factors of PICS-p at 2 months post-PICU [Срок оценки: 2 months after PICU discharge]
  • Develop and validate a model predictive of PICS-p 2 months post PICU [Срок оценки: 2 months after PICU discharge]
Вторичные конечные точки (2)
  • Describe the incidence of each of the five domains of PICS-p across the first two years post-PICU [Срок оценки: At 2 months, 12, 18 months and 36 months post PICU discharge]
  • Uncover additional post-PICU morbidities not detected within the framework of PICS-p. [Срок оценки: Until 36 months post PICU discharge]

Критерии участия

Критерии включения

  • Children ≤18yo hospitalized in PICU for ≥96 hours

Критерии исключения

  • gestational age <37 weeks or age >18 years at PICU entry;
  • admitted for congenital heart surgery (followed in neuro-cardiac clinics in most centers);
  • anticipated life expectancy <1year (e.g., active do not resuscitate status).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 8 центров
  • Alberta Children's Hospital — Calgary
  • BC Children Hospital — Vancouver
  • McMaster Children's Hospital — Hamilton
  • Childrens Hospital of Eastern Ontario — Ottawa
  • The Hospital for Sick Children — Toronto
  • CHU Sainte-Justine — Montreal
  • Montreal Children Hospital — Montreal
  • Centre Hospitalier Universitaire de Sherbrooke — Sherbrooke

Идентификаторы

NCT: NCT06124092 · CHUSJ MP-21-2023-5097

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗