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

Browse trials for

• Heart Defects, Congenital 1,006

Keywords

• Congenital heart disease
• Enteral nutrition
• Pediatrics

Heart Defects, Congenital

1,006 studies on the registry are indexed under Heart Defects, Congenital; 256 are open to participants now.

This study's planned enrollment of 160 is above the median of 60 across 524 interventional studies indexed under Heart Defects, Congenital.

Lead sponsor

Children's Hospital of Fudan University is the lead sponsor of 262 studies on the registry; 92 are open to participants now.

Study arms

• Experimental
  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. 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.

  Dietary Supplement: High energy density enteral nutrition

• Active comparator
  General energy density enteral nutrition

  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.

  Dietary Supplement: General energy density enteral nutrition

Interventions

• Dietary supplementHigh 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.

  Also known as: High energy density EN

• Dietary supplementGeneral 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.

  Also known as: General energy density EN

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

5. Blood lipid levels

   Blood lipid test is to measure the content of lipids in blood.Blood lipids include total cholesterol(0-5.18mmol/L) and triglycerides(0-1.7mmol/L).If it exceeds the range, it will be considered as abnormal.

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

6. Energy intake (cal/d)

   Calculate the caloric intake for enteral feeding according to the Schofeld formula recommended by the European Society for Pediatric and Neonatal Intensive Care (ESPNIC)

   Time frame: During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge

7. Enteral Nutrition intake (ml/d)

   Based on the child's weight and the fluid balance in the previous 24 hours, the total fluid intake for the day is calculated. After subtracting the amount of intravenous drug solution, the amount of enteral nutrition formula is obtained. According to the child's gastrointestinal function, the principle of gradual progress is adopted to rationally allocate the single feeding volume and feeding frequency.

   Time frame: During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge

8. Incidence of malabsorption

   Incidence of malabsorption (as defined by any of the following criteria): abnormal fecal lactose content; abnormal fecal fat content.The diagnosis will be confirmed by fecal examination.

   Time frame: During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge

9. Incidence of feeding intolerance

   Any of the following condition: 1. Frequent vomiting (≥ 3 times/d); 2.Abdominal distension; 3. Milk volume did not increase or decreased\>3 d; 4. Gastric retention (retention\>1/3 of the previous feeding); 5. Unplanned discontinuation of feeding ≥ 2 times; 6. Diarrhea (stool frequency\>6 times/d)

   Time frame: During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge

10. Incidence of necrotizing enterocolitis（NEC）

    NEC diagnosed in stage II and III will be recorded.

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

11. Other surgical indications

    Mechanical ventilation time (days), postoperative CCU hospitalization duration (days), total hospitalization duration (days), hospitalization costs (Yuan), and the incidence of poor wound healing will be recorded.

    Time frame: At the day of discharge, an average of 3 week after surgery