Actively Recruiting

Phase Not Applicable
Age: 0Months - 6Months
All Genders
NCT07115108

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

Led by Children's Hospital of Fudan University · Updated on 2026-05-13

160

Participants Needed

1

Research Sites

63 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0Months - 6Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with congenital heart disease through symptoms, physical signs, imaging, and ultrasound examinations
  • Age 0 to 6 months
  • Nutritional risks as defined by STRONGkids nutritional risk screening tool for children
  • Receiving artificial or mixed feeding
  • Underwent open heart surgery with cardiopulmonary bypass
  • Guardians voluntarily agree to participate and sign informed consent before surgery
Not Eligible

You will not qualify if you...

  • Diagnosed with major non-cardiac diseases causing nutritional intake disorders, such as congenital gastrointestinal malformations, gastroesophageal reflux before surgery, growth-restricting genetic diseases, or chromosomal syndromes (trisomy 21, trisomy 18)
  • Abnormal immune system function from congenital or acquired causes, impairing ability to fight infections or abnormal cells
  • History of neurological diseases before surgery (e.g., encephalitis, epilepsy)
  • Symptoms of gastrointestinal infection like abdominal distension or diarrhea after surgery
  • Estimated postoperative intensive care unit stay of 2 days or less

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 201102

Actively Recruiting

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Research Team

X

Xu Yulu

CONTACT

G

Gu Ying

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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