Actively Recruiting

Age: 0 - 3Months
All Genders
ID05072626

Study on High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia After Kasai Portoenterostomy

Led by Children's Hospital of Fudan University · Updated on 2026-04-03

300

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to study infants with biliary atresia, a serious liver condition that often leads to liver failure and is a common cause for infant liver transplantation. Malnutrition is a frequent complication for these children, especially in the first year, causing reduced muscle mass, weaker bones, low fat reserves, and vitamin deficiencies. The study focuses on improving nutritional care after the Kasai operation, which is a surgery performed to treat biliary atresia, to help improve growth and health outcomes in these infants. Infants up to 3 months old who have had the Kasai surgery and can take nutrition by mouth or tube will receive a high medium-chain triglyceride (MCT) formula combined with breast milk or regular formula if breast milk is insufficient. The MCT formula powder makes up at least 50% of their nutrition, with recommended energy intake set at 100-130% of dietary reference intakes. This nutritional support is provided following the surgery to investigate its effects on growth and nutritional status. Participants will be monitored at multiple time points after surgery, including 1 month, 3 months, 6 months, and 1 year, with measurements of body weight, length, head circumference, vitamin and trace element levels, liver function tests, and other blood tests. Researchers will track growth scores and biochemical markers to assess the nutritional impact of the high MCT formula. This observational study involves 300 hospitalized infants and includes education, intervention, and follow-up to standardize nutrition assessment and care.

CONDITIONS

Brief Title

High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia

Who Can Participate

Age: 0 - 3Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants under 3 months old who have undergone the Kasai procedure for biliary atresia
Not Eligible

You will not qualify if you...

  • Presence of cirrhosis, hepatitis, or other liver disorders
  • Presence of serious systemic diseases such as congenital multiple malformations or chromosome abnormalities

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Nutritional Support

Duration - Up to 12 months after Kasai portoenterostomy

Participants receive high medium-chain triglyceride (MCT) formula nutritional support following Kasai portoenterostomy to improve nutritional status and growth.

Visits at 1 month, 3 months, 6 months, and 1 year after Kasai portoenterostomy

Long-term Monitoring

Duration - Up to 1 year after Kasai portoenterostomy

Participants are monitored for nutritional status, growth, vitamin levels, liver function, and other health outcomes up to one year after Kasai portoenterostomy.

Follow-up visits at 1 month, 3 months, 6 months, and 1 year post-surgery

Trial Site Locations

Total: 1 location

1

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 200000

Actively Recruiting

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Research Team

T

Tian Qian, M.D. PhD

X

Xiaoyan Gong, Bachelor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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