High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia

Study Overview
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Brief Summary
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This study is a prospective, single-center, randomized controlled, parallel, and open clinical study.

Detailed Description
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Medium-chain triglyceride（MCT） remains a key component of supplementation in cholestasis. The limited data point to improved growth in cholestatic infants fed with a ratio of MCT/ long-chain triglyceride (LCT) supplementation of 30% to 70% (MCT/LCT mix). It is important to highlight that MCTs are less efficient fuel sources, as MCTs contain fewer kilocalories per gram than LCTs (8.3 kcal/g MCT vs 9 kcal/g LCT), increase total energy expenditure, and are not a source of essential fatty acids. For this reason, a diet of exclusive MCT lipids (>80%, or lower in severe cholestasis) increases the risk of Essential Fatty Acid Deficiency and may contribute to suboptimal weight gain. Supplementation of the diet with MCT may be offered in the form of both MCT supplementation and MCT-containing formulas. it should be noted that while the practice of enriching the diet with MCT oils in the clinical setting is commonplace, a trial comparing MCT to LCT supplementation has never been performed in pediatric cholestasis. A total of 300 infants with Congenital Biliary Atresia after Kasai Portoenterostomy will be enrolled ( randomly divided 150 in the experimental group and 150 in the control group). To evaluate the efficacy, safety, and tolerance of MCT supplementation with breast milk and formula compared with high MCT formula.

Official Title
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Study on High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia After Kasai Portoenterostomy

Conditions
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Biliary Atresia, Infant, Nutrition Support, Medium-chain Triglyceride

Intervention / Treatment
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* Combination Product: high MCT formula
* Dietary Supplement: MCT powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type III biliary atresia hepatojejunostomy； Gestational age at birth ≥ 36 weeks； Infants aged 0-3months； Weight ≥ 2kg when entering the group； Informed consent of family members Exclusion Criteria: There are known immune deficiencies； Severe surgical complications (such as intestinal obstruction, massive bleeding, etc.) -occurred during or within 72 hours after the operation； The child's mother has human immunodeficiency disease, or HBsAg positive, or HCV positive； Complicated with other systemic serious diseases (such as congenital multiple malformations, chromosome abnormalities)

Ages Eligible for Study
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Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A total of 300 infants < 3 months old with Congenital Biliary Atresia after Kasai Portoenterostomy will be enrolled. Randomized grouping, the patients will be fed with high MCT formula milk with breast milk (or infant formula) or MCT supplementation with breast milk (or infant formula) after the Kasai procedure.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: high MCT formula with breast milk (or infant formula)<br>high MCT formula with breast milk（or infant formula）: Patients will be enrolled from 4 to 5 days after the Kasai operation. Daily dose: according to the amount of enteral nutrition, q2h, q3h, or tube feeding. | Combination Product: high MCT formula<br>* Alfaré(Nestlé Health Science China, including 39% of MCT) with breast milk (or infant formula). Alfaré can be fed with moderate concentration(3.45 tablespoons of 90ml water - 4 tablespoons of 90ml water), and the total energy can be increased by 7.3-16.8kcal/kg/day.<br>|
| Experimental: MCT powder with breast milk (or infant formula)<br>Patients will be enrolled from 4 to 5 days after the Kasai operation. Daily dose: according to the amount of enteral nutrition, q2h, q3h, or tube feeding. | Dietary Supplement: MCT powder<br>* MCT supplement 1-2g/kg/day combined with breast milk (or infant formula), the total energy can be increased by 7.3-14.6kcal/kg/day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biliary Atresia, Kasai portoenterostomy, Nutrition Support, medium-chain triglyceride