Effectiveness of High-Energy Density Enteral Nutrition for Enhancing Physical Growth and Cognitive Brain Development in Infants With Congenital Heart Disease

Last updated: May 12, 2026
Sponsor: Children's Hospital of Fudan University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congenital Heart Disease

Diet And Nutrition

Heart Disease

Treatment

General energy density enteral nutrition

High energy density enteral nutrition

Clinical Study ID

NCT07115108
FNF202531
2024YFC707605
  • Ages < 6
  • All Genders

Study Summary

The purpose of this study is to compare the effect of high and ordinary energy density enteral nutrition for improving physical growth and brain cognitive development in infants with congenital heart disease after operation, as well as evaluate the safety of interventions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with congenital heart disease through symptoms, physical signs, imaging,and ultrasound examinations.

  • Age 0-6 months

  • Children with nutritional risks (defined by STRONGkids: Nutritional risk screeningtool for children )

  • Artificial or mixed feeding

  • Open heart surgery under cardiopulmonary bypass

  • The guardians of the children voluntarily participate in this study and sign awritten informed consent form before the surgery.

Exclusion

Exclusion Criteria:

  • Diagnosed with major non cardiac diseases leading to nutritional intake disorders,such as congenital gastrointestinal malformations, preoperative diagnosis ofgastroesophageal reflux, genetic diseases related to growth restriction, and varioussyndromes with chromosomal abnormalities (trisomy 21 syndrome, trisomy 18 syndrome)

  • Abnormal immune system function due to congenital or acquired factors, unable toeffectively resist pathogens or eliminate abnormal cells, which can be divided intoprimary and secondary immunodeficiencies.

  • Any pre - operative history of neurological diseases (e.g., encephalitis, epilepsy).

  • Secondary or primary gastrointestinal infection symptoms such as abdominaldistension and diarrhea after surgery.

  • Estimated stay time in the postoperative intensive care unit ≤ 2 days

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: General energy density enteral nutrition
Phase:
Study Start date:
October 13, 2025
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Children's Hospital of Fudan University

    Shanghai, Shanghai Municipality 201102
    China

    Active - Recruiting

  • Children's Hospital of Fudan University

    Shanghai 1796236, Shanghai Municipality 1796231 201102
    China

    Site Not Available

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang Uygur Autonomous Region 830054
    China

    Site Not Available

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi 1529102, Xinjiang Uygur Autonomous Region 830054
    China

    Site Not Available

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