High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia
Study on High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia After Kasai Portoenterostomy
1 other identifier
observational
300
1 country
1
Brief Summary
This study is a prospective, single center and observational open clinical study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2021
CompletedFirst Posted
Study publicly available on registry
October 11, 2021
CompletedStudy Start
First participant enrolled
October 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedMarch 13, 2024
March 1, 2024
4.5 years
September 13, 2021
March 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (81)
Z-scores of body length
1 month after Kasai portoenterostomy
Z-scores of body length
3 months after Kasai portoenterostomy
Z-scores of body length
6 months after Kasai portoenterostomy
Z-scores of body length
1 year after Kasai portoenterostomy
Z-scores of body weight
1 month after Kasai portoenterostomy
- +76 more secondary outcomes
Study Arms (1)
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.
Eligibility Criteria
The Kasai procedure for infants with biliary atresia under the age of 3 months.
You may qualify if:
- The Kasai procedure for infants with biliary atresia under the age of 3 months.
You may not qualify if:
- Complicated with cirrhosis, hepatitis, or other hepatic disorders;
- Complicated with other systemic serious diseases (such as congenital multiple malformations, chromosome abnormalities)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 200000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tian Qian, M.D. PhD
Children's Hospital of Fudan University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Director of clinical Nutrition
Study Record Dates
First Submitted
September 13, 2021
First Posted
October 11, 2021
Study Start
October 11, 2021
Primary Completion
March 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
March 13, 2024
Record last verified: 2024-03