Biliary Atresia, Infant, Medium-chain Triglyceride, Nutrition Support
Conditions
Keywords
Biliary Atresia, Kasai portoenterostomy, Nutrition Support, medium-chain triglyceride
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.
Interventions
None listed
Sponsors
Children's Hospital of Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Months
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Z-scores of body weight | 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
| Measure | Time frame | Description |
|---|---|---|
| Z-scores of body length | 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 | 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 | 1 month after Kasai portoenterostomy | Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards. |
| level of vitamin A | 1 month after Kasai portoenterostomy | Blood biochemical data are from clinical database. |
| level of 25（OH) D | 1 month after Kasai portoenterostomy | Blood biochemical data are from clinical database. |
| level of 25（OH） D | 6 months after Kasai portoenterostomy | Blood biochemical data are from clinical database. |
| level of vitamin E | 1 month after Kasai portoenterostomy | Blood biochemical data are from clinical database. |
| level of vitamin K | 1 month after Kasai portoenterostomy | Blood biochemical data are from clinical database. |
| Aspartate aminotransferase | 1 month after Kasai portoenterostomy | Blood biochemical data are from clinical database. |
| Alanine aminotransferase | 1 month after Kasai portoenterostomy | Blood biochemical data are from clinical database. |
| Total Bilirubin | 1 month after Kasai portoenterostomy | Blood biochemical data are from clinical database. |
| Direct Bilirubin | 1 month after Kasai portoenterostomy | Blood biochemical data are from clinical database. |
| Gamma-glutamyl transferase | 1 month after Kasai portoenterostomy | Blood biochemical data are from clinical database. |
| Total bile acid | 1 month after Kasai portoenterostomy | Blood biochemical data are from clinical database. |
| White blood cell | 1 month after Kasai portoenterostomy | Blood biochemical data are from clinical database. |
| lymphocyte | 1 month after Kasai portoenterostomy | Blood biochemical data are from clinical database. |
| Neutrophil count | 1 month after Kasai portoenterostomy | Blood biochemical data are from clinical database. |
| International Normalized Ratio | 1 month after Kasai portoenterostomy | Blood biochemical data are from clinical database. |
| Incidence of postoperative cholangitis | 1 year after Kasai portoenterostomy | Data from clinical database |
| Liver transplantation | 1 year after Kasai portoenterostomy | Data from clinical database |
| MMP-7 | 1 months after Kasai portoenterostomy | Data from clinical database |
| Intestinal flora | 1 months after Kasai portoenterostomy | Data from clinical database |
| bile acid spectrum | 1 months after Kasai portoenterostomy | Data from clinical database |
Countries
China
Contacts
CONTACTTian Qian, M.D. PhD
CONTACTXiaoyan Gong, Bachelor
STUDY_DIRECTORTian Qian, M.D. PhD
Children's Hospital of Fudan University
Outcome results
None listed