Nutritional Intervention for Biliary Atresia

Официальное название

Nutritional Intervention With High Chain Triglyceride Formulation During Perioperative Period of Kasai Surgery for Biliary Atresia: a Prospective Multicenter Trial

Обзор

Infants with biliary atresia (Biliary atresia, BA) have an increased risk of malnutrition due to insufficient dietary intake to maintain normal growth, impaired intestinal absorption, increased metabolic rate, and damage to some liver macronutrient metabolic pathways. The medium-chain triglyceride formula (MCT) in enteral nutrition has advantages: (1) It has a fast metabolism in the liver and possesses the advantage of being an innate energy source; (2) It can share metabolic pathways with some other fatty acids (DHA, EPA), and can promote the synthesis of phospholipids, etc. Therefore, EN containing the MCT formula is regarded as an important approach to alleviate growth retardation in BA children and improve the nutritional status of patients. This study aims to observe the effect of intensified enteral feeding with a high MCT formula during the perioperative period compared to traditional oral feeding on the prognosis of children with biliary atresia. The method adopted is a prospective, two-arm, open-label, multicenter, and interventional real-world study.

Вмешательства

• Пищевая добавка high MCT formula
  Energy Intake: The tube-feeding formula was a special medical-purpose formula food with high MCT and deep hydrolyzed milk protein (Alfare, Nestlé, Switzerland), which contained hydrolyzed whey protein, maltodextrin, vegetable oil, and MCT, etc. At a high-calorie concentration, each 1000 mL could provide 800 kcal, 15.8 g MCT, and 21.5 g protein (osmotic pressure 227 mOsm/kg). Feeding Procedure: On the basis of 130 - 150% DRI, a high-calorie formula feeding amount of 160 ml/kg/d could provide 2.7
• Пищевая добавка normal oral intake of the traditional formula
  For the children in the control group, there were no special restrictions before the operation. After they were able to have a normal diet postoperatively, they were encouraged to have a normal oral intake of the traditional formula. The recommended energy input for the formula was 130 - 150% of the reference intake (DRI) based on age and gender as per the World Health Organization (WHO). The final dosage and schedule were determined by the children and their parents or caregivers. The feeding r

Первичные конечные точки

• age by weight Z score [Срок оценки: 6 months]

Вторичные конечные точки (1)

• age by height Z score [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Infants under 3 months old;
• Children clinically diagnosed with biliary atresia and in need of Kasai surgery;
• The patient themselves, legal representative or guardian have signed the informed consent form and are willing to actively cooperate with treatment and follow-up.

Критерии исключения

• Low birth weight infants or very low birth weight infants;
• Complicated with life-threatening diseases of various organ systems;
• Complicated with other severe digestive tract malformations or other diseases that may interfere with the treatment of the patient or the patient's compliance;
• Patients who have participated in other clinical trials within the last month;
• Any other conditions that the researcher deems unsuitable for participation in this trial.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tongji Hospital — Ухань

Идентификаторы

NCT: NCT06764082 · Nutr-BA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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