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NCT05072626 Clinical Trial

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

Infant Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05072626
Other study ID # (2020)287
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 11, 2021
Est. completion date December 31, 2026

Study information
Verified date March 2024
Source Children's Hospital of Fudan University
Contact Tian Qian, M.D. PhD
Phone +8602164931981
Email drqiantian@fudan.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is a prospective, single center and observational open clinical study.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 31, 2026
Est. primary completion date March 31, 2026
Accepts healthy volunteers No
Gender All
Age group N/A to 3 Months
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Children's Hospital of Fudan University Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Z-scores of body weight The patient will be weighed in the recumbent position on an electronic infant scale. Z-scores for weight for age (WAZ) were obtained from the World Health Organization Anthro software and WHO Child Growth Standards. 3 months after Kasai portoenterostomy
Secondary Z-scores of body length Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards. 1 month after Kasai portoenterostomy
Secondary Z-scores of body length Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards. 3 months after Kasai portoenterostomy
Secondary Z-scores of body length Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards. 6 months after Kasai portoenterostomy
Secondary Z-scores of body length Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards. 1 year after Kasai portoenterostomy
Secondary Z-scores of body weight Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards. 1 month after Kasai portoenterostomy
Secondary Z-scores of body weight Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards. 6 months after Kasai portoenterostomy
Secondary Z-scores of body weight Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards. 1 year after Kasai portoenterostomy
Secondary Z-scores of head circumference Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards. 1 month after Kasai portoenterostomy
Secondary Z-scores of head circumference Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards. 3 months after Kasai portoenterostomy
Secondary Z-scores of head circumference Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards. 6 months after Kasai portoenterostomy
Secondary Z-scores of head circumference Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards. 1 year after Kasai portoenterostomy
Secondary level of vitamin A Blood biochemical data are from clinical database. 1 month after Kasai portoenterostomy
Secondary level of vitamin A Blood biochemical data are from clinical database. 3 months after Kasai portoenterostomy
Secondary level of vitamin A Blood biochemical data are from clinical database. 6 months after Kasai portoenterostomy
Secondary level of vitamin A Blood biochemical data are from clinical database. 1 year after Kasai portoenterostomy
Secondary level of 25(OH) D Blood biochemical data are from clinical database. 1 month after Kasai portoenterostomy
Secondary level of 25(OH) D Blood biochemical data are from clinical database. 3 months after Kasai portoenterostomy
Secondary level of 25(OH) D Blood biochemical data are from clinical database. 6 months after Kasai portoenterostomy
Secondary level of 25(OH) D Blood biochemical data are from clinical database. 1 year after Kasai portoenterostomy
Secondary level of vitamin E Blood biochemical data are from clinical database. 1 month after Kasai portoenterostomy
Secondary level of vitamin E Blood biochemical data are from clinical database. 3 months after Kasai portoenterostomy
Secondary level of vitamin E Blood biochemical data are from clinical database. 6 months after Kasai portoenterostomy
Secondary level of vitamin E Blood biochemical data are from clinical database. 1 year after Kasai portoenterostomy
Secondary level of vitamin K Blood biochemical data are from clinical database. 1 month after Kasai portoenterostomy
Secondary level of vitamin K Blood biochemical data are from clinical database. 3 months after Kasai portoenterostomy
Secondary level of vitamin K Blood biochemical data are from clinical database. 6 months after Kasai portoenterostomy
Secondary level of vitamin K Blood biochemical data are from clinical database. 1 year after Kasai portoenterostomy
Secondary Aspartate aminotransferase Blood biochemical data are from clinical database. 1 month after Kasai portoenterostomy
Secondary Aspartate aminotransferase Blood biochemical data are from clinical database. 3 months after Kasai portoenterostomy
Secondary Aspartate aminotransferase Blood biochemical data are from clinical database. 6 months after Kasai portoenterostomy
Secondary Aspartate aminotransferase Blood biochemical data are from clinical database. 1 year after Kasai portoenterostomy
Secondary Alanine aminotransferase Blood biochemical data are from clinical database. 1 month after Kasai portoenterostomy
Secondary Alanine aminotransferase Blood biochemical data are from clinical database. 3 months after Kasai portoenterostomy
Secondary Alanine aminotransferase Blood biochemical data are from clinical database. 6 months after Kasai portoenterostomy
Secondary Alanine aminotransferase Blood biochemical data are from clinical database. 1 year after Kasai portoenterostomy
Secondary Total Bilirubin Blood biochemical data are from clinical database. 1 month after Kasai portoenterostomy
Secondary Total Bilirubin Blood biochemical data are from clinical database. 3 months after Kasai portoenterostomy
Secondary Total Bilirubin Blood biochemical data are from clinical database. 6 months after Kasai portoenterostomy
Secondary Total Bilirubin Blood biochemical data are from clinical database. 1 year after Kasai portoenterostomy
Secondary Direct Bilirubin Blood biochemical data are from clinical database. 1 month after Kasai portoenterostomy
Secondary Direct Bilirubin Blood biochemical data are from clinical database. 3 months after Kasai portoenterostomy
Secondary Direct Bilirubin Blood biochemical data are from clinical database. 6 months after Kasai portoenterostomy
Secondary Direct Bilirubin Blood biochemical data are from clinical database. 1 year after Kasai portoenterostomy
Secondary Gamma-glutamyl transferase Blood biochemical data are from clinical database. 1 month after Kasai portoenterostomy
Secondary Gamma-glutamyl transferase Blood biochemical data are from clinical database. 3 months after Kasai portoenterostomy
Secondary Gamma-glutamyl transferase Blood biochemical data are from clinical database. 6 months after Kasai portoenterostomy
Secondary Gamma-glutamyl transferase Blood biochemical data are from clinical database. 1 year after Kasai portoenterostomy
Secondary Total bile acid Blood biochemical data are from clinical database. 1 month after Kasai portoenterostomy
Secondary Total bile acid Blood biochemical data are from clinical database. 3 months after Kasai portoenterostomy
Secondary Total bile acid Blood biochemical data are from clinical database. 6 months after Kasai portoenterostomy
Secondary Total bile acid Blood biochemical data are from clinical database. 1 year after Kasai portoenterostomy
Secondary White blood cell Blood biochemical data are from clinical database. 1 month after Kasai portoenterostomy
Secondary White blood cell Blood biochemical data are from clinical database. 3 months after Kasai portoenterostomy
Secondary White blood cell Blood biochemical data are from clinical database. 6 months after Kasai portoenterostomy
Secondary White blood cell Blood biochemical data are from clinical database. 1 year after Kasai portoenterostomy
Secondary lymphocyte Blood biochemical data are from clinical database. 1 month after Kasai portoenterostomy
Secondary lymphocyte Blood biochemical data are from clinical database. 3 months after Kasai portoenterostomy
Secondary lymphocyte Blood biochemical data are from clinical database. 6 months after Kasai portoenterostomy
Secondary lymphocyte Blood biochemical data are from clinical database. 1 year after Kasai portoenterostomy
Secondary Neutrophil count Blood biochemical data are from clinical database. 1 month after Kasai portoenterostomy
Secondary Neutrophil count Blood biochemical data are from clinical database. 3 months after Kasai portoenterostomy
Secondary Neutrophil count Blood biochemical data are from clinical database. 6 months after Kasai portoenterostomy
Secondary Neutrophil count Blood biochemical data are from clinical database. 1 year after Kasai portoenterostomy
Secondary International Normalized Ratio Blood biochemical data are from clinical database. 1 month after Kasai portoenterostomy
Secondary International Normalized Ratio Blood biochemical data are from clinical database. 3 months after Kasai portoenterostomy
Secondary International Normalized Ratio Blood biochemical data are from clinical database. 6 months after Kasai portoenterostomy
Secondary International Normalized Ratio Blood biochemical data are from clinical database. 1 year after Kasai portoenterostomy
Secondary Incidence of postoperative cholangitis Data from clinical database 1 year after Kasai portoenterostomy
Secondary Liver transplantation Data from clinical database 1 year after Kasai portoenterostomy
Secondary MMP-7 Data from clinical database 1 months after Kasai portoenterostomy
Secondary MMP-7 Data from clinical database 3 months after Kasai portoenterostomy
Secondary MMP-7 Data from clinical database 6 months after Kasai portoenterostomy
Secondary MMP-7 Data from clinical database 1 year after Kasai portoenterostomy
Secondary Intestinal flora Data from clinical database 1 months after Kasai portoenterostomy
Secondary Intestinal flora Data from clinical database 3 months after Kasai portoenterostomy
Secondary Intestinal flora Data from clinical database 6 months after Kasai portoenterostomy
Secondary Intestinal flora Data from clinical database 1 year after Kasai portoenterostomy
Secondary bile acid spectrum Data from clinical database 1 months after Kasai portoenterostomy
Secondary bile acid spectrum Data from clinical database 3 months after Kasai portoenterostomy
Secondary bile acid spectrum Data from clinical database 6 months after Kasai portoenterostomy
Secondary bile acid spectrum Data from clinical database 1 year after Kasai portoenterostomy
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