Nutritional Intervention With High Chain Triglyceride Formulation During Perioperative Period of Kasai Surgery for Biliary Atresia: a Prospective Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- age by weight Z score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 3 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
age by weight Z score
时间窗: 6 months
scores
次要结局
- age by height Z score(6 months)
研究者
Feng Jiexiong
pediatric surgery department
Tongji Hospital
