KIDSHEART AND BRAIN : Early EEG Surgery Congenital Heart Disease Predict Onset of Neurodevelopmental Disorders

Официальное название

Intérêt de l'électroencéphalogramme précoce en Chirurgie de Cardiopathie congénitale Pour prédire la Survenue de Troubles du neurodéveloppement

Обзор

Congenital cardiopathy are frequent malformations (1/100 birth). The progress of surgery permit a survival rate at the adult age of more than 90%. The long terms consequences must be taken in account and the nerodevelopmental disorders are in first place (intelectual deficiency, autism spectrum disorders, or attention disorders) and presents in 30 to 60% of the patients (Calmant, 2015). The impact can be important on the scolarity, the studies, the professional activity and finaly on the quality of life of the patients becomming adults. The identification of the risk factors on surgery period should permit to propose the most adapted follow-up to the specifics needs of each patients. On the scientific plans, the identification of early markers on brain dammage on EEG should permit to better apprehend the physiopathologic mecanisms involved.

Подробное описание

Interest of early EEG on congenital cardiopathy surgery to predict the neurodevelopmental disorders occurence.

Congenital cardiopathy are frequent malformations (1/100 birth). The progress of surgery permit a survival rate at the adult age of more than 90%. The long terms consequences must be taken in account and the nerodevelopmental disorders are in first place (intelectual deficiency, autism spectrum disorders, or attention disorders) and presents in 30 to 60% of the patients (Calmant, 2015). The impact can be important on the scolarity, the studies, the professional activity and finaly on the quality of life of the patients becomming adults.

The identification of the risk factors on surgery period should permit to propose the most adapted follow-up to the specifics needs of each patients.

On the scientific plans, the identification of early markers on brain dammage on EEG should permit to better apprehend the physiopathologic mecanisms involved.

Первичные конечные точки

• Interest of pre and post surgery EEG on neurodevelopmental disorders [Срок оценки: Age of patient : 24 Months]

Вторичные конечные точки (2)

• Association between orality disorders and neurodevelopmental disorders [Срок оценки: Age of patient : 24 Months]
• Interest of post surgery EEG neurodevelopmental disorders at 24 months old [Срок оценки: Age of patient : 24 Months]

Критерии участия

Критерии включения

• Child of less than 1 year admitted for cardiac surgery on extracorporal circulation on the CHU of Lille during the study period.
• Child with congenital cardiopathy with necessity to be operated before 1 year old.

Критерии исключения

• Child with no necessity of surgery before 1 year old.
• Medical history of cardiac surgery.
• Refusal of consent by the parents.
• No social security.
• Child not operated on the CHU of LILLE.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• CHU de LILLE — Lille

Публикации

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• Asakai H, Cardamone M, Hutchinson D, Stojanovski B, Galati JC, Cheung MM, Mackay MT. Arterial ischemic stroke in children with cardiac disease. Neurology. 2015 Dec 8;85(23):2053-9. doi: 10.1212/WNL.0000000000002036. Epub 2015 Sep 25. PMID 26408496
• Latal B, Wohlrab G, Brotschi B, Beck I, Knirsch W, Bernet V. Postoperative Amplitude-Integrated Electroencephalography Predicts Four-Year Neurodevelopmental Outcome in Children with Complex Congenital Heart Disease. J Pediatr. 2016 Nov;178:55-60.e1. doi: 10.1016/j.jpeds.2016.06.050. Epub 2016 Jul 22. PMID 27453368

Идентификаторы

NCT: NCT05658965 · 2021_0160 · 2022-A00335-38

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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