High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia
Study Details
Study Description
Brief Summary
This study is a prospective, single-center, randomized controlled, parallel, and open clinical study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: high MCT formula with breast milk (or infant formula) 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
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.
|
| Experimental: MCT powder 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. |
Dietary Supplement: MCT powder
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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 length [3 months after Kasai portoenterostomy]
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
- Z-scores of body length [6 months after Kasai portoenterostomy]
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
- Z-scores of body length [1 year 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 body weight [6 months 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 year 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.
- Z-scores of head circumference [3 months after Kasai portoenterostomy]
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
- Z-scores of head circumference [6 months 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 year 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 vitamin A [3 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- level of vitamin A [6 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- level of vitamin A [1 year 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 [3 months 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 25（OH） D [1 year 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 E [3 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- level of vitamin E [6 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- level of vitamin E [1 year 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.
- level of vitamin K [3 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- level of vitamin K [6 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- level of vitamin K [1 year after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Aspartate aminotransferase [1 month after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Aspartate aminotransferase [3 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Aspartate aminotransferase [6 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Aspartate aminotransferase [1 year after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Alanine aminotransferase [1 month after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Alanine aminotransferase [3 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Alanine aminotransferase [6 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Alanine aminotransferase [1 year after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Total Bilirubin [1 month after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Total Bilirubin [3 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Total Bilirubin [6 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Total Bilirubin [1 year after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Direct Bilirubin [1 month after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Direct Bilirubin [3 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Direct Bilirubin [6 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Direct Bilirubin [1 year 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.
- Gamma-glutamyl transferase [3 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Gamma-glutamyl transferase [6 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Gamma-glutamyl transferase [1 year 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.
- Total bile acid [3 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Total bile acid [6 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Total bile acid [1 year 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.
- White blood cell [3 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- White blood cell [6 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- White blood cell [1 year after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- lymphocyte [1 month after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- lymphocyte [3 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- lymphocyte [6 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- lymphocyte [1 year after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Neutrophil count [1 month after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Neutrophil count [3 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Neutrophil count [6 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- Neutrophil count [1 year 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.
- International Normalized Ratio [3 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- International Normalized Ratio [6 months after Kasai portoenterostomy]
Blood biochemical data are from clinical database.
- International Normalized Ratio [1 year 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
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital of Fudan University | Shanghai | Shanghai | China | 200000 |
Sponsors and Collaborators
- Children's Hospital of Fudan University
Investigators
- Study Director: Tian Qian, M.D. PhD, Children's Hospital of Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- （2020）287