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

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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

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.
    


Study Type

Interventional


Primary Outcome

Z-scores of body weight

Secondary Outcome

 Z-scores of body length

Condition

Biliary Atresia

Intervention

high MCT formula

Study Arms / Comparison Groups

 high MCT formula with breast milk (or infant formula)
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Combination Product

Estimated Enrollment

300

Start Date

October 11, 2021

Completion Date

September 25, 2024

Primary Completion Date

March 31, 2024

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, and CMV infection)
      

Gender

All

Ages

N/A - 3 Months

Accepts Healthy Volunteers

No

Contacts

Tian Qian, M.D. PhD, +8602164931981, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05072626

Organization ID

(2020)287


Responsible Party

Principal Investigator

Study Sponsor

Children's Hospital of Fudan University


Study Sponsor

Tian Qian, M.D. PhD, Study Director, Children's Hospital of Fudan University


Verification Date

November 2021