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Идёт набор NCT05996211

The Swiss Neurodevelopmental Outcome Registry for Children With CHD

— Наблюдательное Neurodevelopmental Abnormality Congenital Heart Disease Cardiac Disease Intensive Care Neurological Disorder

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Neurodevelopmental Abnormality, Congenital Heart Disease, Cardiac Disease, Intensive Care Neurological Disorder. Базовые параметры: 1 Week — 6 Weeks · 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
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Introduction: Congenital heart disease (CHD) is the most frequent birth defect. As survival has significantly improved, attention has turned to neurodevelopmental outcomes of children undergoing heart surgery in early infancy. Since multiple risk factors contribute to neurodevelopmental alterations, a nationwide registry collecting data on medical characteristics, interventions, clinical course and neurodevelopment until school-age is needed to improve the quality of management, identify risk- and protective factors affecting neurodevelopment, and facilitate multicenter trials. Methods and analysis: The Swiss Outcome Registry for CHIldren with severe congenital heart Disease (ORCHID) is a nationwide, prospective, population-based patient registry developed (1) to collect baseline characteristics and clinical data of CHD patients operated with bypass-surgery or hybrid procedures in the first 6 weeks of life in Switzerland, (2) to monitor long-term neurodevelopment, and (3) to relate clinical characteristics and neurodevelopment to identify risk and protective factors in these children. This registry started data collection relating to pregnancy, birth, preoperative course, catheter-based and surgical treatment, postoperative course and reinterventions in 2019. The primary outcome includes standardised neurodevelopmental assessments at 9 to 12 months, 18 to 24 months and 5.5 to 6 years. Investigators expect to include 80 to 100 children per year. Correlation and regression analyses will be used to investigate risk- and protective factors influencing neurodevelopment. Ethics and dissemination of results: Swiss ORCHID received support by the Accentus Charitable Foundation, the Anna Mueller Grocholoski Foundation, the Swiss Society of Pediatric Cardiology, and the Corelina - Foundation and was approved by the cantonal ethics committees. Findings will be presented at national and international scientific meetings, and published in peer-reviewed journals. Results will also be shared with patient organizations, primary health care providers, and public health stakeholders to ensure a widespread dissemination of the results.

Первичные конечные точки

  • Bayley scales of infant and toddler development III at one year of age [Срок оценки: One year of age]
  • Bayley scales of infant and toddler development III at two years of age [Срок оценки: Two years of age]
  • Bayley scales of infant and toddler development III at five years of age [Срок оценки: Five years of age]

Критерии участия

Критерии включения

  • Neonates (including preterm born children) with severe CHD
  • Requiring an invasive cardiac intervention (including heart-lung-machine) within the first 6 weeks of life.

Критерии исключения

  • Neonates (including preterm born children) with simple CHD
  • Requiring simple cardiac surgery or catheter intervention such as closure of patent arterial duct or simple repair of aortic coarctation without heart-lung-machine and low impact on neurodevelopmental outcome.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швейцария · 3 центра
  • University of Bern — Bern
  • University of Lausanne — Lausanne
  • University Children's Hospital — Zurich

Публикации

  • Natterer J, Schneider J, Sekarski N, Rathke V, Adams M, Latal B, Borradori-Tolsa BT, Bouhabib M, Fuhrer Kradolfer K, Glockler M, Hutter D, Kelly J, L'Ebraly C, Pfluger MR, Polito A, von Rhein M, Knirsch W. ORCHID (Outcome Registry for CHIldren with severe congenital heart Disease) a Swiss, nationwide, prospective, population-based, neurodevelopmental paediatric patient registry: framework, regulat PMID 36074038
  • Engeli R, Knirsch W, Rathke V, von Rhein M, L'Ebraly C, Grunt S, Kelly-Geyer JF. Perioperative mortality and 1-year neurodevelopmental outcome after cardiac surgery prior to 6 weeks of age, requiring perioperative extracorporeal membrane oxygenation in the first year of life. Front Cardiovasc Med. 2026 Jun 26;13:1828474. doi: 10.3389/fcvm.2026.1828474. eCollection 2026. PMID 42434149
  • Knirsch W, De Silvestro A, Rathke V, L'Ebraly C, Natterer JC, Schneider J, Sekarski N, Latal B, Borradori-Tolsa C, Bouhabib MS, Fuhrer Kradolfer K, Glockler M, Hutter D, Pfluger MR, Kaiser L, Polito A, Kelly-Geyer JF, von Rhein M; Swiss ORCHID group. Impact of postoperative necrotizing enterocolitis after neonatal cardiac surgery on neurodevelopmental outcome at 1 year of age. Front Pediatr. 2024 PMID 39165487

Идентификаторы

NCT: NCT05996211 · Knirsch 02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗