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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-6
SponsorChildren's Hospital of Fudan University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • High energy density enteral nutrition

    Dietary supplement

    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

    Dietary supplement

    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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: High energy density enteral nutritionExperimental treatment 1 intervention
Group B: General energy density enteral nutritionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Weight-for-age z score (WAZ)

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.

Time frame
6th month after discharge

Secondary outcomes

1

Weight-for-age z score (WAZ)

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.

Time frame
Before discharge, 1st month, 3rd month after discharge
2

Cognitive development

The Griffiths mental development scales (GMDs) will be used to repeatedly measure the indicators .The Griffiths scales typically yield a Developmental Quotient (DQ) with an average range of 85-115. The higher the scores, the more advanced development relative to age norms in assessed domains (e.g., motor, language, or cognition).

Time frame
Before discharge, 1st month, 3rd month, 6th month after discharge
3

Incidence of subjects with Gastrointestinal mucosal barrier function injury

Primarily defined by elevation in fecal calprotectin and Inflammatory cytokines level.The reference range for calprotectin is 0-5 μg/g,inflammatory cytokines is ≤20pg/ml.Exceeding this range will be considered as abnormal gastrointestinal mucosal barrier function.

Time frame
Before discharge, 1 month, 3 months, 6 months after discharge
4

Albumin level

Albumin is a rich protein in the blood, which mainly reflects the nutritional status.The reference range for albumin is 39-54g/L.If it is not within this range, it will be judged as abnormal.

Time frame
Before discharge, 1 month, 3 months, 6 months after discharge

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.