Investigating the effect of adequate energy and protein intake for children after cardiopulmonary bypass surgery

INTERVENTION: Participants will be randomly allocated in a 1:1 ratio to either the control or intervention group using a block randomization method where participants will be stratified into 4 sets of blocks according to their STAT risk category. In the Control Group, a standard formula (1.4 g/100 mL, 67 kcal/100 mL, Nutrilon 1, Nutricia, Nederland B. V.) will be used to provide energy according to the current practice in each center, the amount of protein intake is about 1 g/kg/day. In the New Formula Group, bovine pure whey protein isolate (BiPro, Davisco Foods International, Inc., MN, USA) will be added to the standard formula to achieve protein intake of 4 g/kg/day and energy intake of 60 kcal/kg/day. The formulas will be prepared every 3 hours to prevent bacterial growth and delivered by an infusion pump via a nasogastric tube. In both groups, enteral feeding of the formulas will be initiated at 1 mL/kg/h at 6 hours after cardiopulmonary bypass surgery and increased by 1 mL/kg every 6 hours, until reaching or getting close to the goal energy intakes by 30 hours after cardiopulmonary bypass surgery. In the following 4 days, the daily formulas were made according to study group allocation. CONDITION: Congenital heart disease ; Neonatal Diseases ; Congenital malformations of the circulatory system PRIMARY OUTCOME: ; 1. New infections acquired during the Cardiac Intensive Care Unit (CICU) stay and the duration of antibiotic treatment assessed using patient notes at the time of CICU discharge; 2. The duration of CICU dependency assessed using patient notes at the time of CICU discharge; INCLUSION CRITERIA: 1. Diagnosis of congenital heart disease and planned cardiopulmonary bypass 2. Aged between 1 month and 1 year 3. Informed consent given by parent(s) or legal guardian 4. Gestational age at birth >36 weeks. SECONDARY OUTCOME: ; 1. Mortality:; 1.1. During the first 7 days in the CICU assessed using patient notes at the time of CICU discharge.; 1.2. During the total stay in the CICU assessed using patient notes at the time of CICU discharge.; 1.3. During the total stay in the hospital assessed using patient notes at the time of hospital discharge.; 1.4. At 30 days after admission to the CICU and randomization assessed using investigator records at 30 days after surgery.; 1.5. The rates of survival up to 90 days, regardless of ICU and hospital discharge status assessed using investigator records at 90 days after surgery.; 1.6. The proportion of patients who were alive 8 days after CICU discharge assessed using investigator records at 8 days after CICU discharge.; 2. The number of readmissions to CICU within 48 h assessed using investigator records at 48 h after CICU discharge; 3. The time to final (live) weaning from mechanical ventilatory support assessed using investigator records at the time of weaning; 4. The time to (live) discharge from the hospital assessed using investigator records at the time of hospital discharge; 5. The need for cardiovascular support assessed using the duration of pharmacologic or mechanical hemodynamic support and Vasoactive‐Inotropic Score (VIS) assessed using patient notes at the time of CICU discharge; 6. The rate of organ dysfunction:; 6.1. Renal dysfunction:; 6.1.1. Acute kidney injury defined as at least a doubling of the serum creatinine level recorded on admission, measured through blood samples taken at baseline and every CICU day.; 6.1.2. Proportion of patients requiring renal replacement therapy, and the duration of such; therapy in the ICU, assessed using patient notes after CICU discharge.; 6.2. Liver dysfunction indicated by alanine aminotransferase, aspartate aminotransferase, total bilirubin and albumin, measured through blood samples taken at every CICU day; 6.3. Cardiac dysfunction indicated by NT‐proBNP measured through blood samples taken at every CICU day; 7. Complication rate assessed from the rate of hypoglycemia (glucose level <2.2 mmol per liter), and the rates of hyperglycemia and the doses of insulin given, measured using patient notes at the time of CICU discharge; 8. Nutritional status measured using changes in prealbumin and CRP on blood samples taken at every CICU day, mid‐upper‐arm circumference and triceps skinfold measured using skinfold calipers at the time of CICU discharge, and the rates of feeding intolerance assessed using investigator records at the time of CICU discharge.;