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

Fudan University

Status: Not yet enrolling

Conditions: Pediatrics; Enteral Nutrition; Congenital Heart Disease

Treatments: Dietary Supplement: High energy density enteral nutrition; Dietary Supplement: General energy density enteral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT07115108

FNF

2024YFC707605 (Other Grant/Funding Number)

Details and patient eligibility

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.

Enrollment: 160 estimated patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

High energy density enteral nutrition

Experimental group

Description:

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. Weight measurements and neurological assessments will be conducted at admission, prior to discharge, and at 1-, 3-, and 6-month intervals post-discharge. The safety of the intervention will be closely monitored throughout the study period.

Treatment:

Dietary Supplement: High energy density enteral nutrition

General energy density enteral nutrition

Active Comparator group

Description:

General energy density enteral nutrition (60-88cal/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. Weight measurements and neurological assessments will be conducted at admission, prior to discharge, and at 1-, 3-, and 6-month intervals post-discharge. The safety of the intervention will be closely monitored throughout the study period.

Treatment:

Dietary Supplement: General energy density enteral nutrition