跳至主要内容
临床试验/NCT06764082
NCT06764082招募中不适用

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

Tongji Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年2月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Feng Jiexiong

pediatric surgery department

Tongji Hospital

研究点 (1)

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