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This study is a prospective, single center and observational open clinical 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Z-scores of body length |
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Inclusion Criteria:
The Kasai procedure for infants with biliary atresia under the age of 3 months.
Exclusion Criteria:
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The Kasai procedure for infants with biliary atresia under the age of 3 months.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tian Qian, M.D. PhD | Contact | +8602164931981 | drqiantian@fudan.edu.cn | |
| Xiaoyan Gong, Bachelor | Contact | +8602164931980 | xygongfudan@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Tian Qian, M.D. PhD | Children's Hospital of Fudan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D001656 | Biliary Atresia |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D004065 | Digestive System Abnormalities |
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Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
| 3 months after Kasai portoenterostomy |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| level of vitamin A | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy |
| level of vitamin A | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy |
| level of vitamin A | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy |
| level of vitamin A | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy |
| level of 25（OH) D | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy |
| level of 25（OH) D | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy |
| level of 25（OH） D | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy |
| level of 25（OH） D | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy |
| level of vitamin E | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy |
| level of vitamin E | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy |
| level of vitamin E | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy |
| level of vitamin E | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy |
| level of vitamin K | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy |
| level of vitamin K | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy |
| level of vitamin K | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy |
| level of vitamin K | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy |
| Aspartate aminotransferase | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy |
| Aspartate aminotransferase | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy |
| Aspartate aminotransferase | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy |
| Aspartate aminotransferase | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy |
| Alanine aminotransferase | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy |
| Alanine aminotransferase | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy |
| Alanine aminotransferase | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy |
| Alanine aminotransferase | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy |
| Total Bilirubin | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy |
| Total Bilirubin | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy |
| Total Bilirubin | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy |
| Total Bilirubin | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy |
| Direct Bilirubin | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy |
| Direct Bilirubin | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy |
| Direct Bilirubin | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy |
| Direct Bilirubin | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy |
| Gamma-glutamyl transferase | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy |
| Gamma-glutamyl transferase | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy |
| Gamma-glutamyl transferase | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy |
| Gamma-glutamyl transferase | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy |
| Total bile acid | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy |
| Total bile acid | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy |
| Total bile acid | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy |
| Total bile acid | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy |
| White blood cell | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy |
| White blood cell | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy |
| White blood cell | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy |
| White blood cell | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy |
| lymphocyte | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy |
| lymphocyte | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy |
| lymphocyte | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy |
| lymphocyte | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy |
| Neutrophil count | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy |
| Neutrophil count | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy |
| Neutrophil count | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy |
| Neutrophil count | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy |
| International Normalized Ratio | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy |
| International Normalized Ratio | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy |
| International Normalized Ratio | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy |
| International Normalized Ratio | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy |
| Incidence of postoperative cholangitis | Data from clinical database | 1 year after Kasai portoenterostomy |
| Liver transplantation | Data from clinical database | 1 year after Kasai portoenterostomy |
| MMP-7 | Data from clinical database | 1 months after Kasai portoenterostomy |
| MMP-7 | Data from clinical database | 3 months after Kasai portoenterostomy |
| MMP-7 | Data from clinical database | 6 months after Kasai portoenterostomy |
| MMP-7 | Data from clinical database | 1 year after Kasai portoenterostomy |
| Intestinal flora | Data from clinical database | 1 months after Kasai portoenterostomy |
| Intestinal flora | Data from clinical database | 3 months after Kasai portoenterostomy |
| Intestinal flora | Data from clinical database | 6 months after Kasai portoenterostomy |
| Intestinal flora | Data from clinical database | 1 year after Kasai portoenterostomy |
| bile acid spectrum | Data from clinical database | 1 months after Kasai portoenterostomy |
| bile acid spectrum | Data from clinical database | 3 months after Kasai portoenterostomy |
| bile acid spectrum | Data from clinical database | 6 months after Kasai portoenterostomy |
| bile acid spectrum | Data from clinical database | 1 year after Kasai portoenterostomy |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |