Study on High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia After Kasai Portoenterostomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Z-scores of body weight
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 3 Months (Child)
- Sex
- All
- Accepts 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)
Arms & Interventions
high MCT formula nutritional support
Infants aged 0-3 months who underwent Kasai operation for congenital biliary atresia and were able to receive enteral nutrition through oral or tube feeding were administered a high MCT formula powder + breast milk (with the high MCT formula powder accounting for ≥50%) after the Kasai operation. If breast milk was insufficient, regular formula was used as a substitute. The recommended energy intake was set at 100-130% of DRIs.
Outcomes
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(1 month after Kasai portoenterostomy)
- Z-scores of body length(3 months after Kasai portoenterostomy)
- Z-scores of body length(6 months after Kasai portoenterostomy)
- Z-scores of body weight(1 month after Kasai portoenterostomy)
- Z-scores of body weight(6 months after Kasai portoenterostomy)
- Z-scores of head circumference(1 month after Kasai portoenterostomy)
- Z-scores of head circumference(3 months after Kasai portoenterostomy)
- Z-scores of head circumference(6 months after Kasai portoenterostomy)
- level of vitamin A(1 month after Kasai portoenterostomy)
- level of vitamin A(3 months after Kasai portoenterostomy)
- Intestinal flora(1 months after Kasai portoenterostomy)
- level of vitamin A(6 months after Kasai portoenterostomy)
- level of 25（OH) D(1 month after Kasai portoenterostomy)
- level of 25（OH） D(6 months after Kasai portoenterostomy)
- level of vitamin E(1 month after Kasai portoenterostomy)
- level of vitamin E(3 months after Kasai portoenterostomy)
- level of vitamin E(6 months after Kasai portoenterostomy)
- level of vitamin K(1 month after Kasai portoenterostomy)
- level of vitamin K(3 months after Kasai portoenterostomy)
- level of vitamin K(6 months after Kasai portoenterostomy)
- Aspartate aminotransferase(1 month after Kasai portoenterostomy)
- Aspartate aminotransferase(3 months after Kasai portoenterostomy)
- Aspartate aminotransferase(6 months after Kasai portoenterostomy)
- Alanine aminotransferase(1 month after Kasai portoenterostomy)
- Alanine aminotransferase(3 months after Kasai portoenterostomy)
- Alanine aminotransferase(6 months after Kasai portoenterostomy)
- Total Bilirubin(1 month after Kasai portoenterostomy)
- Total Bilirubin(3 months after Kasai portoenterostomy)
- Total Bilirubin(6 months after Kasai portoenterostomy)
- Direct Bilirubin(1 month after Kasai portoenterostomy)
- Direct Bilirubin(3 months after Kasai portoenterostomy)
- Direct Bilirubin(6 months after Kasai portoenterostomy)
- Gamma-glutamyl transferase(1 month after Kasai portoenterostomy)
- Gamma-glutamyl transferase(3 months after Kasai portoenterostomy)
- Gamma-glutamyl transferase(6 months after Kasai portoenterostomy)
- Total bile acid(1 month after Kasai portoenterostomy)
- Total bile acid(3 months after Kasai portoenterostomy)
- Total bile acid(6 months after Kasai portoenterostomy)
- White blood cell(1 month after Kasai portoenterostomy)
- White blood cell(3 months after Kasai portoenterostomy)
- White blood cell(6 months after Kasai portoenterostomy)
- lymphocyte(1 month after Kasai portoenterostomy)
- lymphocyte(3 months after Kasai portoenterostomy)
- lymphocyte(6 months after Kasai portoenterostomy)
- Neutrophil count(1 month after Kasai portoenterostomy)
- Neutrophil count(3 months after Kasai portoenterostomy)
- Neutrophil count(6 months after Kasai portoenterostomy)
- International Normalized Ratio(1 month after Kasai portoenterostomy)
- International Normalized Ratio(3 months after Kasai portoenterostomy)
- International Normalized Ratio(6 months after Kasai portoenterostomy)
- MMP-7(1 months after Kasai portoenterostomy)
- MMP-7(3 months after Kasai portoenterostomy)
- MMP-7(6 months after Kasai portoenterostomy)
- Intestinal flora(3 months after Kasai portoenterostomy)
- Intestinal flora(6 months after Kasai portoenterostomy)
- bile acid spectrum(1 months after Kasai portoenterostomy)
- bile acid spectrum(3 months after Kasai portoenterostomy)
- bile acid spectrum(6 months after Kasai portoenterostomy)
- Direct Bilirubin(1 year after Kasai portoenterostomy)
- Z-scores of body weight(1 year after Kasai portoenterostomy)
- level of vitamin E(1 year after Kasai portoenterostomy)
- Aspartate aminotransferase(1 year after Kasai portoenterostomy)
- Alanine aminotransferase(1 year after Kasai portoenterostomy)
- level of 25（OH） D(1 year after Kasai portoenterostomy)
- Total bile acid(1 year after Kasai portoenterostomy)
- lymphocyte(1 year after Kasai portoenterostomy)
- Incidence of postoperative cholangitis(1 year after Kasai portoenterostomy)
- MMP-7(1 year after Kasai portoenterostomy)
- Z-scores of head circumference(1 year after Kasai portoenterostomy)
- level of 25（OH) D(3 months after Kasai portoenterostomy)
- International Normalized Ratio(1 year after Kasai portoenterostomy)
- Z-scores of body length(1 year after Kasai portoenterostomy)
- level of vitamin A(1 year after Kasai portoenterostomy)
- level of vitamin K(1 year after Kasai portoenterostomy)
- Liver transplantation(1 year after Kasai portoenterostomy)
- bile acid spectrum(1 year after Kasai portoenterostomy)
- Neutrophil count(1 year after Kasai portoenterostomy)
- Total Bilirubin(1 year after Kasai portoenterostomy)
- Gamma-glutamyl transferase(1 year after Kasai portoenterostomy)
- White blood cell(1 year after Kasai portoenterostomy)
- Intestinal flora(1 year after Kasai portoenterostomy)
Investigators
Qian Tian
Deputy Director of clinical Nutrition
Children's Hospital of Fudan University