High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Biliary Atresia, Infant, Nutrition Support, Medium-chain Triglyceride. Basic parameters: up to 3 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study on High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia After Kasai Portoenterostomy
Overview
This study is a prospective, single center and observational open clinical study.
Detailed description
Biliary atresia (BA) is a significant disease leading to liver failure in infancy, with BA accounting for 50% of infant liver transplantation cases. Many BA children experience complications related to malnutrition, particularly during the first year of life. These complications are primarily characterized by reduced muscle mass and structural protein, impaired bone mineralization, diminished fat reserves, and deficiencies in vitamins and trace elements. Some studies have indicated that oral administration of specialized medium-chain triglycerides (MCT) and branched-chain amino acids FSMP with polysaccharides still result in malnutrition and growth retardation among BA children, necessitating enteral nutrition support treatment through tube feeding. The American Association for the Study of Biliary Atresia conducted a study on the prognosis of 104 children with biliary atresia after Kasai surgery across six clinical centers. They found that the key period for changes in growth rate occurred six months post-surgery, with faster-growing children exhibiting better prognoses compared to those with slower growth rates. Active nutritional therapy can enhance the prognosis of children with biliary atresia, particularly before and after Kasai surgery within the initial six-month period following surgery. Currently, there is no standardized process for using Foods for Special Medical Purpose in China nor any regulations governing the addition and monitoring of trace elements and vitamins. Therefore, this study aims to improve overall outcomes for children with biliary atresia through standardized nutrition assessment procedures as well as education, intervention, and follow-up measures.A total of 300 hospitalized patients were enrolled, all of whom received high MCT formula nutritional support following the Kasai operation, in order to investigate the impact of high MCT formula on the nutritional status and growth of children with biliary atresia after undergoing the Kasai procedure.
Primary outcome measures
- Z-scores of body weight [Time frame: 3 months after Kasai portoenterostomy]
Secondary outcome measures (12)
- Z-scores of body length [Time frame: 1 month after Kasai portoenterostomy]
- Z-scores of body length [Time frame: 3 months after Kasai portoenterostomy]
- Z-scores of body length [Time frame: 6 months after Kasai portoenterostomy]
- Z-scores of body length [Time frame: 1 year after Kasai portoenterostomy]
- Z-scores of body weight [Time frame: 1 month after Kasai portoenterostomy]
- Z-scores of body weight [Time frame: 6 months after Kasai portoenterostomy]
- Z-scores of body weight [Time frame: 1 year after Kasai portoenterostomy]
- Z-scores of head circumference [Time frame: 1 month after Kasai portoenterostomy]
- Z-scores of head circumference [Time frame: 3 months after Kasai portoenterostomy]
- Z-scores of head circumference [Time frame: 6 months after Kasai portoenterostomy]
- Z-scores of head circumference [Time frame: 1 year after Kasai portoenterostomy]
- level of vitamin A [Time frame: 1 month after Kasai portoenterostomy]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Children's Hospital of Fudan University — Shanghai
Identifiers
NCT: NCT05072626 · （2020）287