Actively Recruiting

Phase Not Applicable
Age: 1Day - 3Months
All Genders
ID06764082

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

Age: 1Day - 3Months
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Treatment

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

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Childhood Liver Disease Research Network (ChiLDReN): A Prosp...

Biliary Atresia

Actively Recruiting

16 locations

Bern Birth Cohort Study on Microbiota Maturation in Healthy ...

Maturation of the Healthy Infant Intestinal Microbiota

Actively Recruiting

1 location

BILACO Trial: Biliary Atresia - a Severe Complex Congenital ...

Biliary Atresia

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here