Actively Recruiting
Nutritional Intervention With High Chain Triglyceride Formula During Perioperative Period of Kasai Surgery for Biliary Atresia: a Prospective Multicenter Trial
Led by Tongji Hospital · Updated on 2025-12-22
120
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Infants with biliary atresia (BA) face a high risk of malnutrition due to problems like poor dietary intake, difficulty absorbing nutrients, higher metabolism, and liver-related metabolic issues. Researchers are studying how intensified enteral feeding using a high medium-chain triglyceride (MCT) formula during the perioperative period affects the growth and prognosis of children with BA. This is a prospective, randomized, open-label, multicenter interventional study comparing this approach to traditional oral feeding methods. The study compares two groups: one receiving a high MCT formula designed to provide 800 kcal per 1000 mL with 15.8 g of MCT and 21.5 g of protein, given at 160 mL/kg/day to supply 2.7 g/kg/day of MCT; the other group receives a normal traditional formula with energy intake based on 130-150% of the recommended dietary intake (DRI). Feeding amounts and schedules are tailored by the children and their caregivers, with the experimental feeding beginning post-operation and continuing for six months, including supplementation via nasogastric tube if needed. Participants will be infants under 3 months old diagnosed with biliary atresia and scheduled for Kasai surgery. Researchers will monitor growth through measurements like age-adjusted weight and height Z scores at six months. The study includes regular follow-up visits for nutritional assessment and feeding adjustments. Participants’ nutritional status and response to the feeding protocols will be recorded to assess the impact on growth and recovery over the study period.
CONDITIONS
Brief Title
Nutritional Intervention for Biliary Atresia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants under 3 months old
- Clinically diagnosed with biliary atresia
- Scheduled for Kasai surgery
- Patient or legal guardian has signed informed consent and agrees to cooperate with treatment and follow-up
You will not qualify if you...
- Low birth weight or very low birth weight infants
- Life-threatening diseases affecting various organ systems
- Severe digestive tract malformations or other diseases interfering with treatment or compliance
- Participation in other clinical trials within the last month
- Any other condition deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 6 months after Kasai surgery
Participants receive nutritional intervention with either a high medium-chain triglyceride (MCT) formula or a traditional formula starting around the time of Kasai surgery and continuing for up to 6 months after the operation.
Visits occur as per treatment and follow-up schedules; specific visit frequency is determined by clinical care
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China, 430030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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