Infant Clinical Trial
Official title:
Study on High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia After Kasai Portoenterostomy
This study is a prospective, single center and observational open clinical study.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2026 |
Est. primary completion date | March 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 3 Months |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
China | Children's Hospital of Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Z-scores of body length | Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards. | 3 months after Kasai portoenterostomy | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | level of vitamin A | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy | |
Secondary | level of vitamin A | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy | |
Secondary | level of vitamin A | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy | |
Secondary | level of vitamin A | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy | |
Secondary | level of 25(OH) D | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy | |
Secondary | level of 25(OH) D | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy | |
Secondary | level of 25(OH) D | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy | |
Secondary | level of 25(OH) D | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy | |
Secondary | level of vitamin E | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy | |
Secondary | level of vitamin E | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy | |
Secondary | level of vitamin E | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy | |
Secondary | level of vitamin E | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy | |
Secondary | level of vitamin K | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy | |
Secondary | level of vitamin K | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy | |
Secondary | level of vitamin K | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy | |
Secondary | level of vitamin K | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy | |
Secondary | Aspartate aminotransferase | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy | |
Secondary | Aspartate aminotransferase | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy | |
Secondary | Aspartate aminotransferase | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy | |
Secondary | Aspartate aminotransferase | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy | |
Secondary | Alanine aminotransferase | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy | |
Secondary | Alanine aminotransferase | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy | |
Secondary | Alanine aminotransferase | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy | |
Secondary | Alanine aminotransferase | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy | |
Secondary | Total Bilirubin | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy | |
Secondary | Total Bilirubin | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy | |
Secondary | Total Bilirubin | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy | |
Secondary | Total Bilirubin | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy | |
Secondary | Direct Bilirubin | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy | |
Secondary | Direct Bilirubin | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy | |
Secondary | Direct Bilirubin | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy | |
Secondary | Direct Bilirubin | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy | |
Secondary | Gamma-glutamyl transferase | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy | |
Secondary | Gamma-glutamyl transferase | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy | |
Secondary | Gamma-glutamyl transferase | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy | |
Secondary | Gamma-glutamyl transferase | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy | |
Secondary | Total bile acid | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy | |
Secondary | Total bile acid | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy | |
Secondary | Total bile acid | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy | |
Secondary | Total bile acid | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy | |
Secondary | White blood cell | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy | |
Secondary | White blood cell | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy | |
Secondary | White blood cell | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy | |
Secondary | White blood cell | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy | |
Secondary | lymphocyte | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy | |
Secondary | lymphocyte | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy | |
Secondary | lymphocyte | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy | |
Secondary | lymphocyte | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy | |
Secondary | Neutrophil count | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy | |
Secondary | Neutrophil count | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy | |
Secondary | Neutrophil count | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy | |
Secondary | Neutrophil count | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy | |
Secondary | International Normalized Ratio | Blood biochemical data are from clinical database. | 1 month after Kasai portoenterostomy | |
Secondary | International Normalized Ratio | Blood biochemical data are from clinical database. | 3 months after Kasai portoenterostomy | |
Secondary | International Normalized Ratio | Blood biochemical data are from clinical database. | 6 months after Kasai portoenterostomy | |
Secondary | International Normalized Ratio | Blood biochemical data are from clinical database. | 1 year after Kasai portoenterostomy | |
Secondary | Incidence of postoperative cholangitis | Data from clinical database | 1 year after Kasai portoenterostomy | |
Secondary | Liver transplantation | Data from clinical database | 1 year after Kasai portoenterostomy | |
Secondary | MMP-7 | Data from clinical database | 1 months after Kasai portoenterostomy | |
Secondary | MMP-7 | Data from clinical database | 3 months after Kasai portoenterostomy | |
Secondary | MMP-7 | Data from clinical database | 6 months after Kasai portoenterostomy | |
Secondary | MMP-7 | Data from clinical database | 1 year after Kasai portoenterostomy | |
Secondary | Intestinal flora | Data from clinical database | 1 months after Kasai portoenterostomy | |
Secondary | Intestinal flora | Data from clinical database | 3 months after Kasai portoenterostomy | |
Secondary | Intestinal flora | Data from clinical database | 6 months after Kasai portoenterostomy | |
Secondary | Intestinal flora | Data from clinical database | 1 year after Kasai portoenterostomy | |
Secondary | bile acid spectrum | Data from clinical database | 1 months after Kasai portoenterostomy | |
Secondary | bile acid spectrum | Data from clinical database | 3 months after Kasai portoenterostomy | |
Secondary | bile acid spectrum | Data from clinical database | 6 months after Kasai portoenterostomy | |
Secondary | bile acid spectrum | Data from clinical database | 1 year after Kasai portoenterostomy |
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