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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 3 months
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Tongji Hospital
RECRUITING
Wuhan
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 120
Treatments
Experimental: high MCT group
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). On the basis of 130 - 150% DRI, a high-calorie formula feeding amount of 160 ml/kg/d could provide 2.7 g/kg/d MCT.
Active_comparator: normal treatment group
The recommended energy input was 130-150% of the reference intake (DRI) based on age and gender as per WHO. The final dosage and schedule were determined by the children and their parents or caregivers.
Related Therapeutic Areas
Sponsors
Leads: Tongji Hospital

This content was sourced from clinicaltrials.gov