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| Name | Class |
|---|---|
| Danone Institute International | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | High-calorie density formula (1 kcal/ml) |
|
| Control arm | Placebo Comparator | Standard formula (0.67 kcal/ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-calorie density formula (1 kcal/ml) | Dietary Supplement | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | After 3 months of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Calorie intake | Numeric data of the infants' total calorie intake (kcal/kg/day) during hospitalization | From the date of randomization to the date of discharge, assessed up to 3 months |
| Weight |
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Inclusion Criteria:
Exclusion Criteria:
Drop-out
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| Name | Affiliation | Role |
|---|---|---|
| Reni Fitriasari, MD | National Cardiovascular Center Harapan Kita | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cardiovascular Center Harapan Kita | Jakarta | 11420 | Indonesia |
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| Standard formula (0.67 kcal/ml) | Dietary Supplement | 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). |
|
Numeric data of absolute weight (kg)
| After 1, 2, and 3 months of intervention |
| Length | Numeric data of absolute length (cm) | 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 | 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 | 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 | 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 | After 1, 2, and 3 months of intervention |
| Mortality | The event proportion of mortality (%) | Through study completion, an average of 3 months |
| Duration of mechanical ventilation | The difference of mechanical ventilation duration (hours) | 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) | 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 | From the date of randomization to the date of hospital discharge, assessed up to 3 months |
| ID | Term |
|---|---|
| D015362 | Child Nutrition Disorders |
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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