Nutritional support for infants with biliary atresia
Official title: Study on High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia After Kasai Portoenterostomy
Run by Children's Hospital of Fudan University · NCT05072626 · Data updated 2026-11-12
This study is testing if a special high-fat diet can help infants with biliary atresia grow better and stay healthy after their surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 3 Months |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | October 11, 2021 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | April 3, 2026 |
| Trial ID | NCT05072626 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants under 3 months old who have undergone the Kasai procedure for biliary atresia.
✕Probably not a fit
Patients with complications such as cirrhosis, hepatitis, or other serious systemic diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on infants diagnosed with biliary atresia, a condition that can lead to liver failure. It aims to assess the impact of high medium-chain triglyceride nutritional support on the growth and nutritional status of these infants, particularly during the critical period following the Kasai procedure. The study will monitor the nutritional outcomes and growth rates of infants receiving specialized nutritional therapy, addressing the common complications of malnutrition associated with biliary atresia. The research is conducted at a single center, the Children's Hospital of Fudan University, and aims to establish better nutritional practices for this vulnerable population.
Why it matters
Potential benefit: If successful, this study could improve growth and nutritional outcomes for infants with biliary atresia, potentially enhancing their overall prognosis.
How similar studies have gone: While there have been studies on nutritional support in biliary atresia, this specific approach focusing on medium-chain triglycerides is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: The Kasai procedure for infants with biliary atresia under the age of 3 months. Exclusion Criteria: * Complicated with cirrhosis, hepatitis, or other hepatic disorders; * Complicated with other systemic serious diseases (such as congenital multiple malformations, chromosome abnormalities)
Where it's running
-
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Tian Qian, M.D. PhD
- Email: drqiantian@fudan.edu.cn
- Phone: +8602164931981
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Umbilical cord stem cells added during Kasai to help biliary atresia
This early-stage trial tests whether injecting umbilical cord mesenchymal stem cells during Kasai portoenterostomy is safe and helpful for infants with biliary atresia.
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See if a computer program can help diagnose cholestasis in newborns using parent-provided stool images
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Indocyanine green for diagnosing biliary atresia
This test tries to see if a harmless fluorescent dye (indocyanine green) can show whether infants under 3 months with cholestasis have blocked bile ducts (biliary atresia).
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Using near-infrared ICG dye to check bile flow in newborns with cholestasis
We will give eligible newborns a single IV dose of indocyanine green (ICG) to see if the dye appears in their diapers, which would indicate bile is flowing and the bile ducts are open.
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This study is testing if measuring lactate levels in the blood after surgery can help predict complications in infants aged 0-1 year.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.