Clinical trial NCT05072626: High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia
Official title: Study on High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia After Kasai Portoenterostomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Biliary Atresia
Infant
Nutrition Support
Medium-chain Triglyceride
Keywords: Biliary Atresia
Kasai portoenterostomy
Nutrition Support
medium-chain triglyceride
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2021-10-11
Enrollment: 300
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Kasai procedure for infants with biliary atresia under the age of 3 months.

Brief summary: 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.

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)

Primary outcomes:
measure: Z-scores of body weight
timeFrame: 3 months after Kasai portoenterostomy
Secondary outcomes:
measure: Z-scores of body length
timeFrame: 1 month after Kasai portoenterostomy
measure: Z-scores of body length
timeFrame: 3 months after Kasai portoenterostomy
measure: Z-scores of body length
timeFrame: 6 months after Kasai portoenterostomy
measure: Z-scores of body length
timeFrame: 1 year after Kasai portoenterostomy
measure: Z-scores of body weight
timeFrame: 1 month after Kasai portoenterostomy
measure: Z-scores of body weight
timeFrame: 6 months after Kasai portoenterostomy
measure: Z-scores of body weight
timeFrame: 1 year after Kasai portoenterostomy
measure: Z-scores of head circumference
timeFrame: 1 month after Kasai portoenterostomy
measure: Z-scores of head circumference
timeFrame: 3 months after Kasai portoenterostomy
measure: Z-scores of head circumference
timeFrame: 6 months after Kasai portoenterostomy
measure: Z-scores of head circumference
timeFrame: 1 year after Kasai portoenterostomy
measure: level of vitamin A
timeFrame: 1 month after Kasai portoenterostomy
measure: level of vitamin A
timeFrame: 3 months after Kasai portoenterostomy
measure: level of vitamin A
timeFrame: 6 months after Kasai portoenterostomy
measure: level of vitamin A
timeFrame: 1 year after Kasai portoenterostomy
measure: level of 25（OH) D
timeFrame: 1 month after Kasai portoenterostomy
measure: level of 25（OH) D
timeFrame: 3 months after Kasai portoenterostomy
measure: level of 25（OH） D
timeFrame: 6 months after Kasai portoenterostomy
measure: level of 25（OH） D
timeFrame: 1 year after Kasai portoenterostomy
measure: level of vitamin E
timeFrame: 1 month after Kasai portoenterostomy
measure: level of vitamin E
timeFrame: 3 months after Kasai portoenterostomy
measure: level of vitamin E
timeFrame: 6 months after Kasai portoenterostomy
measure: level of vitamin E
timeFrame: 1 year after Kasai portoenterostomy
measure: level of vitamin K
timeFrame: 1 month after Kasai portoenterostomy
measure: level of vitamin K
timeFrame: 3 months after Kasai portoenterostomy
measure: level of vitamin K
timeFrame: 6 months after Kasai portoenterostomy
measure: level of vitamin K
timeFrame: 1 year after Kasai portoenterostomy
measure: Aspartate aminotransferase
timeFrame: 1 month after Kasai portoenterostomy
measure: Aspartate aminotransferase
timeFrame: 3 months after Kasai portoenterostomy
measure: Aspartate aminotransferase
timeFrame: 6 months after Kasai portoenterostomy
measure: Aspartate aminotransferase
timeFrame: 1 year after Kasai portoenterostomy
measure: Alanine aminotransferase
timeFrame: 1 month after Kasai portoenterostomy
measure: Alanine aminotransferase
timeFrame: 3 months after Kasai portoenterostomy
measure: Alanine aminotransferase
timeFrame: 6 months after Kasai portoenterostomy
measure: Alanine aminotransferase
timeFrame: 1 year after Kasai portoenterostomy
measure: Total Bilirubin
timeFrame: 1 month after Kasai portoenterostomy
measure: Total Bilirubin
timeFrame: 3 months after Kasai portoenterostomy
measure: Total Bilirubin
timeFrame: 6 months after Kasai portoenterostomy
measure: Total Bilirubin
timeFrame: 1 year after Kasai portoenterostomy
measure: Direct Bilirubin
timeFrame: 1 month after Kasai portoenterostomy
measure: Direct Bilirubin
timeFrame: 3 months after Kasai portoenterostomy
measure: Direct Bilirubin
timeFrame: 6 months after Kasai portoenterostomy
measure: Direct Bilirubin
timeFrame: 1 year after Kasai portoenterostomy
measure: Gamma-glutamyl transferase
timeFrame: 1 month after Kasai portoenterostomy
measure: Gamma-glutamyl transferase
timeFrame: 3 months after Kasai portoenterostomy
measure: Gamma-glutamyl transferase
timeFrame: 6 months after Kasai portoenterostomy
measure: Gamma-glutamyl transferase
timeFrame: 1 year after Kasai portoenterostomy
measure: Total bile acid
timeFrame: 1 month after Kasai portoenterostomy
measure: Total bile acid
timeFrame: 3 months after Kasai portoenterostomy
measure: Total bile acid
timeFrame: 6 months after Kasai portoenterostomy
measure: Total bile acid
timeFrame: 1 year after Kasai portoenterostomy
measure: White blood cell
timeFrame: 1 month after Kasai portoenterostomy
measure: White blood cell
timeFrame: 3 months after Kasai portoenterostomy
measure: White blood cell
timeFrame: 6 months after Kasai portoenterostomy
measure: White blood cell
timeFrame: 1 year after Kasai portoenterostomy
measure: lymphocyte
timeFrame: 1 month after Kasai portoenterostomy
measure: lymphocyte
timeFrame: 3 months after Kasai portoenterostomy
measure: lymphocyte
timeFrame: 6 months after Kasai portoenterostomy
measure: lymphocyte
timeFrame: 1 year after Kasai portoenterostomy
measure: Neutrophil count
timeFrame: 1 month after Kasai portoenterostomy
measure: Neutrophil count
timeFrame: 3 months after Kasai portoenterostomy
measure: Neutrophil count
timeFrame: 6 months after Kasai portoenterostomy
measure: Neutrophil count
timeFrame: 1 year after Kasai portoenterostomy
measure: International Normalized Ratio
timeFrame: 1 month after Kasai portoenterostomy
measure: International Normalized Ratio
timeFrame: 3 months after Kasai portoenterostomy
measure: International Normalized Ratio
timeFrame: 6 months after Kasai portoenterostomy
measure: International Normalized Ratio
timeFrame: 1 year after Kasai portoenterostomy
measure: Incidence of postoperative cholangitis
timeFrame: 1 year after Kasai portoenterostomy
measure: Liver transplantation
timeFrame: 1 year after Kasai portoenterostomy
measure: MMP-7
timeFrame: 1 months after Kasai portoenterostomy
measure: MMP-7
timeFrame: 3 months after Kasai portoenterostomy
measure: MMP-7
timeFrame: 6 months after Kasai portoenterostomy
measure: MMP-7
timeFrame: 1 year after Kasai portoenterostomy
measure: Intestinal flora
timeFrame: 1 months after Kasai portoenterostomy
measure: Intestinal flora
timeFrame: 3 months after Kasai portoenterostomy
measure: Intestinal flora
timeFrame: 6 months after Kasai portoenterostomy
measure: Intestinal flora
timeFrame: 1 year after Kasai portoenterostomy
measure: bile acid spectrum
timeFrame: 1 months after Kasai portoenterostomy
measure: bile acid spectrum
timeFrame: 3 months after Kasai portoenterostomy
measure: bile acid spectrum
timeFrame: 6 months after Kasai portoenterostomy
measure: bile acid spectrum
timeFrame: 1 year after Kasai portoenterostomy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Tian Qian, M.D. PhD
role: STUDY_DIRECTOR
References: