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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
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 (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.
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region, China
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
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
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
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
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.
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Time frame: Before discharge, 1 month, 3 months, 6 months after discharge
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
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
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
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
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
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
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