High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia
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: Biliary Atresia, Infant, Nutrition Support, Medium-chain Triglyceride. Базовые параметры: до 3 мес. · 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
- Китай
- 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
Study on High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia After Kasai Portoenterostomy
Обзор
This study is a prospective, single center and observational open clinical study.
Подробное описание
Biliary atresia (BA) is a significant disease leading to liver failure in infancy, with BA accounting for 50% of infant liver transplantation cases. Many BA children experience complications related to malnutrition, particularly during the first year of life. These complications are primarily characterized by reduced muscle mass and structural protein, impaired bone mineralization, diminished fat reserves, and deficiencies in vitamins and trace elements. Some studies have indicated that oral administration of specialized medium-chain triglycerides (MCT) and branched-chain amino acids FSMP with polysaccharides still result in malnutrition and growth retardation among BA children, necessitating enteral nutrition support treatment through tube feeding. The American Association for the Study of Biliary Atresia conducted a study on the prognosis of 104 children with biliary atresia after Kasai surgery across six clinical centers. They found that the key period for changes in growth rate occurred six months post-surgery, with faster-growing children exhibiting better prognoses compared to those with slower growth rates. Active nutritional therapy can enhance the prognosis of children with biliary atresia, particularly before and after Kasai surgery within the initial six-month period following surgery. Currently, there is no standardized process for using Foods for Special Medical Purpose in China nor any regulations governing the addition and monitoring of trace elements and vitamins. Therefore, this study aims to improve overall outcomes for children with biliary atresia through standardized nutrition assessment procedures as well as education, intervention, and follow-up measures.A total of 300 hospitalized patients were enrolled, all of whom received high MCT formula nutritional support following the Kasai operation, in order to investigate the impact of high MCT formula on the nutritional status and growth of children with biliary atresia after undergoing the Kasai procedure.
Первичные конечные точки
- Z-scores of body weight [Срок оценки: 3 months after Kasai portoenterostomy]
Вторичные конечные точки (12)
- Z-scores of body length [Срок оценки: 1 month after Kasai portoenterostomy]
- Z-scores of body length [Срок оценки: 3 months after Kasai portoenterostomy]
- Z-scores of body length [Срок оценки: 6 months after Kasai portoenterostomy]
- Z-scores of body length [Срок оценки: 1 year after Kasai portoenterostomy]
- Z-scores of body weight [Срок оценки: 1 month after Kasai portoenterostomy]
- Z-scores of body weight [Срок оценки: 6 months after Kasai portoenterostomy]
- Z-scores of body weight [Срок оценки: 1 year after Kasai portoenterostomy]
- Z-scores of head circumference [Срок оценки: 1 month after Kasai portoenterostomy]
- Z-scores of head circumference [Срок оценки: 3 months after Kasai portoenterostomy]
- Z-scores of head circumference [Срок оценки: 6 months after Kasai portoenterostomy]
- Z-scores of head circumference [Срок оценки: 1 year after Kasai portoenterostomy]
- level of vitamin A [Срок оценки: 1 month after Kasai portoenterostomy]
Критерии участия
Критерии включения
The Kasai procedure for infants with biliary atresia under the age of 3 months.
Критерии исключения
- Complicated with cirrhosis, hepatitis, or other hepatic disorders;
- Complicated with other systemic serious diseases (such as congenital multiple malformations, chromosome abnormalities)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- Children's Hospital of Fudan University — Шанхай
Идентификаторы
NCT: NCT05072626 · (2020)287