Congenital Heart Disease in Children, Malnutrition, Child
Conditions
Keywords
anthropometry, congenital heart disease, infant formula, nutritional status, randomized controlled trial
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTHigh-calorie density formula (1 kcal/ml)
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).
DIETARY_SUPPLEMENTStandard formula (0.67 kcal/ml)
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).
Sponsors
Danone Institute International
National Cardiovascular Center Harapan Kita Hospital Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Days to 1 Years
Healthy volunteers
No
Inclusion criteria
* Patient of less than 1 year of age who underwent congenital heart surgery procedure in Harapan Kita National Cardiovascular Center * Risk adjustment for congenital heart surgery (RACHS) score 2-4 * Patients who do not get exclusive breastfeeding due to any cause
Exclusion criteria
* History of prematurity (\<37 weeks gestational age) * Formula intolerance or cow milk protein allergy * Lethal chromosome abnormality * Galactosemia * Gastrointestinal malformation or obstruction * Renal failure * Liver disease * Metabolic abnormalities * Need for extracorporeal membrane oxygenation Drop-out * Patients who develop diarrhea for more than 5 days during the study period despite getting adequate therapy * Patients who need prolonged total parenteral nutrition (e.g., gastrointestinal bleeding due to any cause, chylothorax, etc.) * Patients with necrotizing enterocolitis during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional status | After 3 months of intervention | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Calorie intake | From the date of randomization to the date of discharge, assessed up to 3 months | Numeric data of the infants' total calorie intake (kcal/kg/day) during hospitalization |
| Weight | After 1, 2, and 3 months of intervention | Numeric data of absolute weight (kg) |
| Length | After 1, 2, and 3 months of intervention | Numeric data of absolute length (cm) |
| Weight-for-age z-score changes | From the date of randomization to after 1, 2, and 3 months of intervention | Difference of weight-for-age z-score based on The 2006 WHO Child Growth Standard |
| Length-for-age z-score changes | From the date of randomization to after 1, 2, and 3 months of intervention | Difference of length-for-age z-score based on The 2006 WHO Child Growth Standard |
| Weight-for-length z-score changes | From the date of randomization to after 1, 2, and 3 months of intervention | Difference of weight-for-length z-score based on The 2006 WHO Child Growth Standard |
| Malnutrition risk | After 1, 2, and 3 months of intervention | Risk ratios of malnutrition, defined as weight-for-length \<-2 based on 2006 WHO Child Growth Standard |
| Mortality | Through study completion, an average of 3 months | The event proportion of mortality (%) |
| Duration of mechanical ventilation | From the date of randomization to the date of hospital discharge, assessed up to 3 months | The difference of mechanical ventilation duration (hours) |
| Length of stay | From the date of randomization to the date of discharge, assessed up to 3 months | The difference of lengths of stay in intensive care unit and hospital (days) |
| Side effects | From the date of randomization to the date of hospital discharge, assessed up to 3 months | The event proportion (%) of vomiting, diarrhea, gastrointestinal bleeding, constipation, and \>50% residual gastric content |
Countries
Indonesia
Outcome results
None listed