Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 200000, China
Location status: Recruiting
Location contact
Tian Qian, M.D.
CONTACT
Xianyan Gong, Bachelor
CONTACT
Recruiting
NCT Number: NCT05072626
High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia
This study is a prospective, single center and observational open clinical study.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
Up to 3 month
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
Primary outcomes
-
Z-scores of body weight
Time frame: 3 months after Kasai portoenterostomy
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.
Secondary outcomes
-
Z-scores of body length
Time frame: 1 month after Kasai portoenterostomy
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
-
Z-scores of body length
Time frame: 3 months after Kasai portoenterostomy
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
-
Z-scores of body length
Time frame: 6 months after Kasai portoenterostomy
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
-
Z-scores of body length
Time frame: 1 year after Kasai portoenterostomy
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
-
Z-scores of body weight
Time frame: 1 month after Kasai portoenterostomy
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
-
Z-scores of body weight
Time frame: 6 months after Kasai portoenterostomy
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
-
Z-scores of body weight
Time frame: 1 year after Kasai portoenterostomy
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
-
Z-scores of head circumference
Time frame: 1 month after Kasai portoenterostomy
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
-
Z-scores of head circumference
Time frame: 3 months after Kasai portoenterostomy
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
-
Z-scores of head circumference
Time frame: 6 months after Kasai portoenterostomy
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
-
Z-scores of head circumference
Time frame: 1 year after Kasai portoenterostomy
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
-
level of vitamin A
Time frame: 1 month after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
level of vitamin A
Time frame: 3 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
level of vitamin A
Time frame: 6 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
level of vitamin A
Time frame: 1 year after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
level of 25（OH) D
Time frame: 1 month after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
level of 25（OH) D
Time frame: 3 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
level of 25（OH） D
Time frame: 6 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
level of 25（OH） D
Time frame: 1 year after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
level of vitamin E
Time frame: 1 month after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
level of vitamin E
Time frame: 3 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
level of vitamin E
Time frame: 6 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
level of vitamin E
Time frame: 1 year after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
level of vitamin K
Time frame: 1 month after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
level of vitamin K
Time frame: 3 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
level of vitamin K
Time frame: 6 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
level of vitamin K
Time frame: 1 year after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Aspartate aminotransferase
Time frame: 1 month after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Aspartate aminotransferase
Time frame: 3 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Aspartate aminotransferase
Time frame: 6 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Aspartate aminotransferase
Time frame: 1 year after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Alanine aminotransferase
Time frame: 1 month after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Alanine aminotransferase
Time frame: 3 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Alanine aminotransferase
Time frame: 6 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Alanine aminotransferase
Time frame: 1 year after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Total Bilirubin
Time frame: 1 month after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Total Bilirubin
Time frame: 3 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Total Bilirubin
Time frame: 6 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Total Bilirubin
Time frame: 1 year after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Direct Bilirubin
Time frame: 1 month after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Direct Bilirubin
Time frame: 3 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Direct Bilirubin
Time frame: 6 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Direct Bilirubin
Time frame: 1 year after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Gamma-glutamyl transferase
Time frame: 1 month after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Gamma-glutamyl transferase
Time frame: 3 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Gamma-glutamyl transferase
Time frame: 6 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Gamma-glutamyl transferase
Time frame: 1 year after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Total bile acid
Time frame: 1 month after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Total bile acid
Time frame: 3 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Total bile acid
Time frame: 6 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Total bile acid
Time frame: 1 year after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
White blood cell
Time frame: 1 month after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
White blood cell
Time frame: 3 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
White blood cell
Time frame: 6 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
White blood cell
Time frame: 1 year after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
lymphocyte
Time frame: 1 month after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
lymphocyte
Time frame: 3 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
lymphocyte
Time frame: 6 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
lymphocyte
Time frame: 1 year after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Neutrophil count
Time frame: 1 month after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Neutrophil count
Time frame: 3 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Neutrophil count
Time frame: 6 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Neutrophil count
Time frame: 1 year after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
International Normalized Ratio
Time frame: 1 month after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
International Normalized Ratio
Time frame: 3 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
International Normalized Ratio
Time frame: 6 months after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
International Normalized Ratio
Time frame: 1 year after Kasai portoenterostomy
Blood biochemical data are from clinical database.
-
Incidence of postoperative cholangitis
Time frame: 1 year after Kasai portoenterostomy
Data from clinical database
-
Liver transplantation
Time frame: 1 year after Kasai portoenterostomy
Data from clinical database
-
MMP-7
Time frame: 1 months after Kasai portoenterostomy
Data from clinical database
-
MMP-7
Time frame: 3 months after Kasai portoenterostomy
Data from clinical database
-
MMP-7
Time frame: 6 months after Kasai portoenterostomy
Data from clinical database
-
MMP-7
Time frame: 1 year after Kasai portoenterostomy
Data from clinical database
-
Intestinal flora
Time frame: 1 months after Kasai portoenterostomy
Data from clinical database
-
Intestinal flora
Time frame: 3 months after Kasai portoenterostomy
Data from clinical database
-
Intestinal flora
Time frame: 6 months after Kasai portoenterostomy
Data from clinical database
-
Intestinal flora
Time frame: 1 year after Kasai portoenterostomy
Data from clinical database
-
bile acid spectrum
Time frame: 1 months after Kasai portoenterostomy
Data from clinical database
-
bile acid spectrum
Time frame: 3 months after Kasai portoenterostomy
Data from clinical database
-
bile acid spectrum
Time frame: 6 months after Kasai portoenterostomy
Data from clinical database
-
bile acid spectrum
Time frame: 1 year after Kasai portoenterostomy
Data from clinical database
Study contacts
Contact information is provided by the study sponsor or research team.
Tian Qian, M.D. PhD
CONTACT
Xiaoyan Gong, Bachelor
CONTACT
Sponsors and collaborators
Lead sponsor
Children's Hospital of Fudan University
Other
Registry information
Official study title
Study on High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia After Kasai Portoenterostomy
Important dates
- Study start
- 2021
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Oct 11, 2021
- Registry last updated
- Apr 3, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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