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Clinical Trials in China / NCT07115108
Recruiting Not applicable

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

NCT07115108 · tracked via the Priya Life Science China tracker
Sponsor
Children's Hospital of Fudan University
Phase
Not applicable
Started
2025-10-13
Last updated
2026-05-13

Condition(s) studied

Congenital Heart DiseaseEnteral NutritionPediatrics

Investigational drug(s) / intervention(s)

High energy density enteral nutritionGeneral energy density enteral nutrition

High energy density enteral nutrition: High-energy-density enteral nutrition (100 cal/100 ml) will be administered to infants following surgery for congenital heart disease. The target feeding volume will be determined based on the infant's body weight (80-100 ml/kg), with the volume per feeding and frequency appropriately adjusted.

General energy density enteral nutrition: General energy density enteral nutrition (60-88 cal/100 ml) will be administered to infants following surgery for congenital heart disease. The target feeding volume will be determined based on the infant's body weight (80-100 ml/kg), with the volume per feeding and frequency appropriately adjusted.

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

Sex
ALL
Min age
0 Months
Max age
6 Months
Healthy volunteers
No
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 screening tool for children ) * Artificial or mixed feeding * Open heart surgery under cardiopulmonary bypass * The guardians of the children voluntarily participate in this study and sign a written informed consent form before the surgery. Exclusion Criteria: * Diagnosed with major non cardiac diseases leading to nutritional intake disorders, such as congenital gastrointestinal malformations, preoperative diagnosis of gastroesophageal reflux, genetic diseases related to growth restriction, and various syndromes with chromosomal abnormalities (trisomy 21 syndrome, trisomy 18 syndrome) * Abnormal immune system function due to congenital or acquired factors, unable to effectively resist pathogens or eliminate abnormal cells, which can be divided into primary and secondary immunodeficiencies. * Any pre - operative history of neurological diseases (e.g., encephalitis, epilepsy). * Secondary or primary gastrointestinal infection symptoms such as abdominal distension and diarrhea after surgery. * Estimated stay time in the postoperative intensive care unit ≤ 2 days

Primary outcome measure(s)

  • Weight-for-age z score (WAZ) — 6th month after discharge
    WAZ is calculated according to the Chinese child growth curve and cut-offs .It is a statistical index used to assess the nutritional status of children. The physical examination will be conducted by a nurse, and the data will be recorded to one decimal place.

Trial sites (1)

FacilityCityRegionStatus
Children's Hospital of Fudan University Shanghai Shanghai Municipality Recruiting

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Other trials for the same condition

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Peri-operative Nutrition in Infants With Congenital Heart Disease Recruiting
Exergame-Based Physical Activity Promotion for Children and Adolescents With Congenital Heart Disease Starting soon
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07115108 on ClinicalTrials.gov ↗ ← All trials in China