The goal of this clinical trial is to compare the effect of high-calorie density formula (HDF) and standard formula (SF) in infants with congenital heart surgery. The main questions it aims to answer are: 1. Is there any difference in nutritional status between both groups after 3 months? 2. Is there any difference in calorie intake per day between both groups during hospitalization? 3. Is there any difference in clinical outcomes (mortality, duration of using mechanical ventilation, length of stay, and events of side effects) between both groups? A group of participants will be given HDF (1 kcal/ml) from enrollment until three months. Researchers will compare them to the group of participants who are given SF (0.67 kcal/ml) to see if there is any difference in nutritional status, calorie intake, and other clinical outcomes between the two groups.
The study is a randomized, double-blind controlled trial to compare the efficacy of HDF formula compared to SF in nutritional and clinical outcomes among infants who had congenital heart surgery in Harapan Kita National Cardiovascular Centre (HKNCC), Jakarta, Indonesia. The researchers use consecutive sampling to include eligible infants and obtain informed consent from the parent or legal guardian of infants who fulfilled the eligibility criteria. Block randomization is done by a research assistant, and then the allocation is prepared using a sealed envelope to assign infants into HDF and SF groups. Participants are then assessed by a multi-professional team and given enteral feeds based on local guidelines. Routine follow-up is done at 2 weeks, 1 month, 2 months, and 3 months after the intervention to record weight, length, and any episode of complication or adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
158
The dose is started from 20ml/kg/day divided into 8 feeds and increased by 20ml/kg/day until the feeding goal is reached (120-150ml/kg/day) during hospitalization. The intervention is then continued after discharge for 3 months (ad libitum).
The dose is started from 20ml/kg/day divided into 8 feeds and increased by 20ml/kg/day until the feeding goal is reached (120-150ml/kg/day) during hospitalization. The intervention is then continued after discharge for 3 months (ad libitum).
National Cardiovascular Center Harapan Kita
Jakarta, Indonesia
Nutritional status
Numeric data of weight-for-length z-score (WLZ), length-for-age z-score (LAZ) and weight-for-age z-score (WAZ) based on the 2006 World Health Organization (WHO) Child Growth Standard
Time frame: After 3 months of intervention
Calorie intake
Numeric data of the infants' total calorie intake (kcal/kg/day) during hospitalization
Time frame: From the date of randomization to the date of discharge, assessed up to 3 months
Weight
Numeric data of absolute weight (kg)
Time frame: After 1, 2, and 3 months of intervention
Length
Numeric data of absolute length (cm)
Time frame: After 1, 2, and 3 months of intervention
Weight-for-age z-score changes
Difference of weight-for-age z-score based on The 2006 WHO Child Growth Standard
Time frame: From the date of randomization to after 1, 2, and 3 months of intervention
Length-for-age z-score changes
Difference of length-for-age z-score based on The 2006 WHO Child Growth Standard
Time frame: From the date of randomization to after 1, 2, and 3 months of intervention
Weight-for-length z-score changes
Difference of weight-for-length z-score based on The 2006 WHO Child Growth Standard
Time frame: From the date of randomization to after 1, 2, and 3 months of intervention
Malnutrition risk
Risk ratios of malnutrition, defined as weight-for-length \<-2 based on 2006 WHO Child Growth Standard
Time frame: After 1, 2, and 3 months of intervention
Mortality
The event proportion of mortality (%)
Time frame: Through study completion, an average of 3 months
Duration of mechanical ventilation
The difference of mechanical ventilation duration (hours)
Time frame: From the date of randomization to the date of hospital discharge, assessed up to 3 months
Length of stay
The difference of lengths of stay in intensive care unit and hospital (days)
Time frame: From the date of randomization to the date of discharge, assessed up to 3 months
Side effects
The event proportion (%) of vomiting, diarrhea, gastrointestinal bleeding, constipation, and \>50% residual gastric content
Time frame: From the date of randomization to the date of hospital discharge, assessed up to 3 months
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