High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia
Primary Purpose
Biliary Atresia, Infant, Nutrition Support
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
high MCT formula
MCT powder
Sponsored by
About this trial
This is an interventional supportive care trial for Biliary Atresia focused on measuring Biliary Atresia, Kasai portoenterostomy, Nutrition Support, medium-chain triglyceride
Eligibility 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)
Sites / Locations
- Children's Hospital of Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
high MCT formula with breast milk (or infant formula)
MCT powder with breast milk (or infant formula)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Z-scores of body length
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Z-scores of body length
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Z-scores of body length
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Z-scores of body length
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Z-scores of body weight
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Z-scores of body weight
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Z-scores of body weight
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Z-scores of head circumference
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Z-scores of head circumference
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Z-scores of head circumference
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Z-scores of head circumference
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
level of vitamin A
Blood biochemical data are from clinical database.
level of vitamin A
Blood biochemical data are from clinical database.
level of vitamin A
Blood biochemical data are from clinical database.
level of vitamin A
Blood biochemical data are from clinical database.
level of 25(OH) D
Blood biochemical data are from clinical database.
level of 25(OH) D
Blood biochemical data are from clinical database.
level of 25(OH) D
Blood biochemical data are from clinical database.
level of 25(OH) D
Blood biochemical data are from clinical database.
level of vitamin E
Blood biochemical data are from clinical database.
level of vitamin E
Blood biochemical data are from clinical database.
level of vitamin E
Blood biochemical data are from clinical database.
level of vitamin E
Blood biochemical data are from clinical database.
level of vitamin K
Blood biochemical data are from clinical database.
level of vitamin K
Blood biochemical data are from clinical database.
level of vitamin K
Blood biochemical data are from clinical database.
level of vitamin K
Blood biochemical data are from clinical database.
Aspartate aminotransferase
Blood biochemical data are from clinical database.
Aspartate aminotransferase
Blood biochemical data are from clinical database.
Aspartate aminotransferase
Blood biochemical data are from clinical database.
Aspartate aminotransferase
Blood biochemical data are from clinical database.
Alanine aminotransferase
Blood biochemical data are from clinical database.
Alanine aminotransferase
Blood biochemical data are from clinical database.
Alanine aminotransferase
Blood biochemical data are from clinical database.
Alanine aminotransferase
Blood biochemical data are from clinical database.
Total Bilirubin
Blood biochemical data are from clinical database.
Total Bilirubin
Blood biochemical data are from clinical database.
Total Bilirubin
Blood biochemical data are from clinical database.
Total Bilirubin
Blood biochemical data are from clinical database.
Direct Bilirubin
Blood biochemical data are from clinical database.
Direct Bilirubin
Blood biochemical data are from clinical database.
Direct Bilirubin
Blood biochemical data are from clinical database.
Direct Bilirubin
Blood biochemical data are from clinical database.
Gamma-glutamyl transferase
Blood biochemical data are from clinical database.
Gamma-glutamyl transferase
Blood biochemical data are from clinical database.
Gamma-glutamyl transferase
Blood biochemical data are from clinical database.
Gamma-glutamyl transferase
Blood biochemical data are from clinical database.
Total bile acid
Blood biochemical data are from clinical database.
Total bile acid
Blood biochemical data are from clinical database.
Total bile acid
Blood biochemical data are from clinical database.
Total bile acid
Blood biochemical data are from clinical database.
White blood cell
Blood biochemical data are from clinical database.
White blood cell
Blood biochemical data are from clinical database.
White blood cell
Blood biochemical data are from clinical database.
White blood cell
Blood biochemical data are from clinical database.
lymphocyte
Blood biochemical data are from clinical database.
lymphocyte
Blood biochemical data are from clinical database.
lymphocyte
Blood biochemical data are from clinical database.
lymphocyte
Blood biochemical data are from clinical database.
Neutrophil count
Blood biochemical data are from clinical database.
Neutrophil count
Blood biochemical data are from clinical database.
Neutrophil count
Blood biochemical data are from clinical database.
Neutrophil count
Blood biochemical data are from clinical database.
International Normalized Ratio
Blood biochemical data are from clinical database.
International Normalized Ratio
Blood biochemical data are from clinical database.
International Normalized Ratio
Blood biochemical data are from clinical database.
International Normalized Ratio
Blood biochemical data are from clinical database.
Incidence of postoperative cholangitis
Data from clinical database
Liver transplantation
Data from clinical database
Full Information
NCT ID
NCT05072626
First Posted
September 13, 2021
Last Updated
February 7, 2023
Sponsor
Children's Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT05072626
Brief Title
High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia
Official Title
Study on High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia After Kasai Portoenterostomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2021 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
September 25, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a prospective, single-center, randomized controlled, parallel, and open clinical study.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Atresia, Infant, Nutrition Support, Medium-chain Triglyceride
Keywords
Biliary Atresia, Kasai portoenterostomy, Nutrition Support, medium-chain triglyceride
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
high MCT formula with breast milk (or infant formula)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MCT powder with breast milk (or infant formula)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
high MCT formula
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
MCT powder
Intervention Description
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.
Primary Outcome Measure Information:
Title
Z-scores of body weight
Description
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.
Time Frame
3 months after Kasai portoenterostomy
Secondary Outcome Measure Information:
Title
Z-scores of body length
Description
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Time Frame
1 month after Kasai portoenterostomy
Title
Z-scores of body length
Description
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Time Frame
3 months after Kasai portoenterostomy
Title
Z-scores of body length
Description
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Time Frame
6 months after Kasai portoenterostomy
Title
Z-scores of body length
Description
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Time Frame
1 year after Kasai portoenterostomy
Title
Z-scores of body weight
Description
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Time Frame
1 month after Kasai portoenterostomy
Title
Z-scores of body weight
Description
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Time Frame
6 months after Kasai portoenterostomy
Title
Z-scores of body weight
Description
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Time Frame
1 year after Kasai portoenterostomy
Title
Z-scores of head circumference
Description
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Time Frame
1 month after Kasai portoenterostomy
Title
Z-scores of head circumference
Description
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Time Frame
3 months after Kasai portoenterostomy
Title
Z-scores of head circumference
Description
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Time Frame
6 months after Kasai portoenterostomy
Title
Z-scores of head circumference
Description
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Time Frame
1 year after Kasai portoenterostomy
Title
level of vitamin A
Description
Blood biochemical data are from clinical database.
Time Frame
1 month after Kasai portoenterostomy
Title
level of vitamin A
Description
Blood biochemical data are from clinical database.
Time Frame
3 months after Kasai portoenterostomy
Title
level of vitamin A
Description
Blood biochemical data are from clinical database.
Time Frame
6 months after Kasai portoenterostomy
Title
level of vitamin A
Description
Blood biochemical data are from clinical database.
Time Frame
1 year after Kasai portoenterostomy
Title
level of 25(OH) D
Description
Blood biochemical data are from clinical database.
Time Frame
1 month after Kasai portoenterostomy
Title
level of 25(OH) D
Description
Blood biochemical data are from clinical database.
Time Frame
3 months after Kasai portoenterostomy
Title
level of 25(OH) D
Description
Blood biochemical data are from clinical database.
Time Frame
6 months after Kasai portoenterostomy
Title
level of 25(OH) D
Description
Blood biochemical data are from clinical database.
Time Frame
1 year after Kasai portoenterostomy
Title
level of vitamin E
Description
Blood biochemical data are from clinical database.
Time Frame
1 month after Kasai portoenterostomy
Title
level of vitamin E
Description
Blood biochemical data are from clinical database.
Time Frame
3 months after Kasai portoenterostomy
Title
level of vitamin E
Description
Blood biochemical data are from clinical database.
Time Frame
6 months after Kasai portoenterostomy
Title
level of vitamin E
Description
Blood biochemical data are from clinical database.
Time Frame
1 year after Kasai portoenterostomy
Title
level of vitamin K
Description
Blood biochemical data are from clinical database.
Time Frame
1 month after Kasai portoenterostomy
Title
level of vitamin K
Description
Blood biochemical data are from clinical database.
Time Frame
3 months after Kasai portoenterostomy
Title
level of vitamin K
Description
Blood biochemical data are from clinical database.
Time Frame
6 months after Kasai portoenterostomy
Title
level of vitamin K
Description
Blood biochemical data are from clinical database.
Time Frame
1 year after Kasai portoenterostomy
Title
Aspartate aminotransferase
Description
Blood biochemical data are from clinical database.
Time Frame
1 month after Kasai portoenterostomy
Title
Aspartate aminotransferase
Description
Blood biochemical data are from clinical database.
Time Frame
3 months after Kasai portoenterostomy
Title
Aspartate aminotransferase
Description
Blood biochemical data are from clinical database.
Time Frame
6 months after Kasai portoenterostomy
Title
Aspartate aminotransferase
Description
Blood biochemical data are from clinical database.
Time Frame
1 year after Kasai portoenterostomy
Title
Alanine aminotransferase
Description
Blood biochemical data are from clinical database.
Time Frame
1 month after Kasai portoenterostomy
Title
Alanine aminotransferase
Description
Blood biochemical data are from clinical database.
Time Frame
3 months after Kasai portoenterostomy
Title
Alanine aminotransferase
Description
Blood biochemical data are from clinical database.
Time Frame
6 months after Kasai portoenterostomy
Title
Alanine aminotransferase
Description
Blood biochemical data are from clinical database.
Time Frame
1 year after Kasai portoenterostomy
Title
Total Bilirubin
Description
Blood biochemical data are from clinical database.
Time Frame
1 month after Kasai portoenterostomy
Title
Total Bilirubin
Description
Blood biochemical data are from clinical database.
Time Frame
3 months after Kasai portoenterostomy
Title
Total Bilirubin
Description
Blood biochemical data are from clinical database.
Time Frame
6 months after Kasai portoenterostomy
Title
Total Bilirubin
Description
Blood biochemical data are from clinical database.
Time Frame
1 year after Kasai portoenterostomy
Title
Direct Bilirubin
Description
Blood biochemical data are from clinical database.
Time Frame
1 month after Kasai portoenterostomy
Title
Direct Bilirubin
Description
Blood biochemical data are from clinical database.
Time Frame
3 months after Kasai portoenterostomy
Title
Direct Bilirubin
Description
Blood biochemical data are from clinical database.
Time Frame
6 months after Kasai portoenterostomy
Title
Direct Bilirubin
Description
Blood biochemical data are from clinical database.
Time Frame
1 year after Kasai portoenterostomy
Title
Gamma-glutamyl transferase
Description
Blood biochemical data are from clinical database.
Time Frame
1 month after Kasai portoenterostomy
Title
Gamma-glutamyl transferase
Description
Blood biochemical data are from clinical database.
Time Frame
3 months after Kasai portoenterostomy
Title
Gamma-glutamyl transferase
Description
Blood biochemical data are from clinical database.
Time Frame
6 months after Kasai portoenterostomy
Title
Gamma-glutamyl transferase
Description
Blood biochemical data are from clinical database.
Time Frame
1 year after Kasai portoenterostomy
Title
Total bile acid
Description
Blood biochemical data are from clinical database.
Time Frame
1 month after Kasai portoenterostomy
Title
Total bile acid
Description
Blood biochemical data are from clinical database.
Time Frame
3 months after Kasai portoenterostomy
Title
Total bile acid
Description
Blood biochemical data are from clinical database.
Time Frame
6 months after Kasai portoenterostomy
Title
Total bile acid
Description
Blood biochemical data are from clinical database.
Time Frame
1 year after Kasai portoenterostomy
Title
White blood cell
Description
Blood biochemical data are from clinical database.
Time Frame
1 month after Kasai portoenterostomy
Title
White blood cell
Description
Blood biochemical data are from clinical database.
Time Frame
3 months after Kasai portoenterostomy
Title
White blood cell
Description
Blood biochemical data are from clinical database.
Time Frame
6 months after Kasai portoenterostomy
Title
White blood cell
Description
Blood biochemical data are from clinical database.
Time Frame
1 year after Kasai portoenterostomy
Title
lymphocyte
Description
Blood biochemical data are from clinical database.
Time Frame
1 month after Kasai portoenterostomy
Title
lymphocyte
Description
Blood biochemical data are from clinical database.
Time Frame
3 months after Kasai portoenterostomy
Title
lymphocyte
Description
Blood biochemical data are from clinical database.
Time Frame
6 months after Kasai portoenterostomy
Title
lymphocyte
Description
Blood biochemical data are from clinical database.
Time Frame
1 year after Kasai portoenterostomy
Title
Neutrophil count
Description
Blood biochemical data are from clinical database.
Time Frame
1 month after Kasai portoenterostomy
Title
Neutrophil count
Description
Blood biochemical data are from clinical database.
Time Frame
3 months after Kasai portoenterostomy
Title
Neutrophil count
Description
Blood biochemical data are from clinical database.
Time Frame
6 months after Kasai portoenterostomy
Title
Neutrophil count
Description
Blood biochemical data are from clinical database.
Time Frame
1 year after Kasai portoenterostomy
Title
International Normalized Ratio
Description
Blood biochemical data are from clinical database.
Time Frame
1 month after Kasai portoenterostomy
Title
International Normalized Ratio
Description
Blood biochemical data are from clinical database.
Time Frame
3 months after Kasai portoenterostomy
Title
International Normalized Ratio
Description
Blood biochemical data are from clinical database.
Time Frame
6 months after Kasai portoenterostomy
Title
International Normalized Ratio
Description
Blood biochemical data are from clinical database.
Time Frame
1 year after Kasai portoenterostomy
Title
Incidence of postoperative cholangitis
Description
Data from clinical database
Time Frame
1 year after Kasai portoenterostomy
Title
Liver transplantation
Description
Data from clinical database
Time Frame
1 year after Kasai portoenterostomy
10. Eligibility
Sex
All
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tian Qian, M.D. PhD
Phone
+8602164931981
Email
drqiantian@fudan.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoyan Gong, Bachelor
Phone
+8602164931980
Email
xygongfudan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tian Qian, M.D. PhD
Organizational Affiliation
Children's Hospital of Fudan University
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tian Qian, M.D.
Phone
02164931981
Email
drqiantian@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Xianyan Gong, Bachelor
Phone
02164931980
Email
xygongfudan@163.com
12. IPD Sharing Statement
Learn more about this trial
High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia
We'll reach out to this number within 24 hrs