Идёт набор NCT07115108
Effectiveness of High-Energy Density Enteral Nutrition for Enhancing Physical Growth and Cognitive Brain Development in Infants With Congenital Heart Disease
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: High energy density enteral nutrition, General energy density enteral nutrition.
- Кому может быть актуально
- Состояния в реестре: Congenital Heart Disease, Enteral Nutrition, Pediatrics. Базовые параметры: 0 мес. — 6 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
Effectiveness of High-Energy Density Enteral Nutrition for Enhancing Physical Growth and Cognitive Brain Development in Infants With Congenital Heart Disease: A Randomized Controlled Study
Обзор
The purpose of this study is to compare the effect of high and ordinary energy density enteral nutrition for improving physical growth and brain cognitive development in infants with congenital heart disease after operation, as well as evaluate the safety of interventions.
Вмешательства
- Пищевая добавка High energy density enteral nutrition
High-energy-density enteral nutrition (100 cal/100 ml) will be administered to infants following surgery for congenital heart disease. The target feeding volume will be determined based on the infant's body weight (80-100 ml/kg), with the volume per feeding and frequency appropriately adjusted. - Пищевая добавка General energy density enteral nutrition
General energy density enteral nutrition (60-88 cal/100 ml) will be administered to infants following surgery for congenital heart disease. The target feeding volume will be determined based on the infant's body weight (80-100 ml/kg), with the volume per feeding and frequency appropriately adjusted.
Первичные конечные точки
- Weight-for-age z score (WAZ) [Срок оценки: 6th month after discharge]
Вторичные конечные точки (11)
- Weight-for-age z score (WAZ) [Срок оценки: Before discharge, 1st month, 3rd month after discharge]
- Cognitive development [Срок оценки: Before discharge, 1st month, 3rd month, 6th month after discharge]
- Incidence of subjects with Gastrointestinal mucosal barrier function injury [Срок оценки: Before discharge, 1 month, 3 months, 6 months after discharge]
- Albumin level [Срок оценки: Before discharge, 1 month, 3 months, 6 months after discharge]
- Blood lipid levels [Срок оценки: Before discharge, 1 month, 3 months, 6 months after discharge]
- Energy intake (cal/d) [Срок оценки: During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge]
- Enteral Nutrition intake (ml/d) [Срок оценки: During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge]
- Incidence of malabsorption [Срок оценки: During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge]
- Incidence of feeding intolerance [Срок оценки: During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge]
- Incidence of necrotizing enterocolitis（NEC） [Срок оценки: Before discharge, 1 month, 3 months, 6 months after discharge]
- Other surgical indications [Срок оценки: At the day of discharge, an average of 3 week after surgery]
Критерии участия
Критерии включения
- Diagnosed with congenital heart disease through symptoms, physical signs, imaging, and ultrasound examinations.
- Age 0-6 months
- Children with nutritional risks (defined by STRONGkids: Nutritional risk screening tool for children )
- Artificial or mixed feeding
- Open heart surgery under cardiopulmonary bypass
- The guardians of the children voluntarily participate in this study and sign a written informed consent form before the surgery.
Критерии исключения
- Diagnosed with major non cardiac diseases leading to nutritional intake disorders, such as congenital gastrointestinal malformations, preoperative diagnosis of gastroesophageal reflux, genetic diseases related to growth restriction, and various syndromes with chromosomal abnormalities (trisomy 21 syndrome, trisomy 18 syndrome)
- Abnormal immune system function due to congenital or acquired factors, unable to effectively resist pathogens or eliminate abnormal cells, which can be divided into primary and secondary immunodeficiencies.
- Any pre - operative history of neurological diseases (e.g., encephalitis, epilepsy).
- Secondary or primary gastrointestinal infection symptoms such as abdominal distension and diarrhea after surgery.
- Estimated stay time in the postoperative intensive care unit ≤ 2 days
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Children's Hospital of Fudan University — Шанхай
Идентификаторы
NCT: NCT07115108 · FNF202531 · 2024YFC707605