Back to resultsThe Effect of High-Calorie Formula on Nutritional and Clinical Outcomes Among Infants After Congenital Heart Surgery
Primary Purpose
Congenital Heart Disease in Children, Malnutrition, Child
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
High-calorie density formula (1 kcal/ml)
Standard formula (0.67 kcal/ml)
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Heart Disease in Children focused on measuring anthropometry, congenital heart disease, infant formula, nutritional status, randomized controlled trial
Eligibility Criteria
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
Sites / Locations
- National Cardiovascular Center Harapan Kita
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention arm
Control arm
Arm Description
High-calorie density formula (1 kcal/ml)
Standard formula (0.67 kcal/ml)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Calorie intake
Numeric data of the infants' total calorie intake (kcal/kg/day) during hospitalization
Weight
Numeric data of absolute weight (kg)
Length
Numeric data of absolute length (cm)
Weight-for-age z-score changes
Difference of weight-for-age z-score based on The 2006 WHO Child Growth Standard
Length-for-age z-score changes
Difference of length-for-age z-score based on The 2006 WHO Child Growth Standard
Weight-for-length z-score changes
Difference of weight-for-length z-score based on The 2006 WHO Child Growth Standard
Malnutrition risk
Risk ratios of malnutrition, defined as weight-for-length <-2 based on 2006 WHO Child Growth Standard
Mortality
The event proportion of mortality (%)
Duration of mechanical ventilation
The difference of mechanical ventilation duration (hours)
Length of stay
The difference of lengths of stay in intensive care unit and hospital (days)
Side effects
The event proportion (%) of vomiting, diarrhea, gastrointestinal bleeding, constipation, and >50% residual gastric content
Full Information
NCT ID
NCT05945459
First Posted
June 14, 2023
Last Updated
July 11, 2023
Sponsor
National Cardiovascular Center Harapan Kita Hospital Indonesia
Collaborators
Danone Institute International
1. Study Identification
Unique Protocol Identification Number
NCT05945459
Brief Title
The Effect of High-Calorie Formula on Nutritional and Clinical Outcomes Among Infants After Congenital Heart Surgery
Official Title
The Effect of High-calorie Density Formula Versus Standard Formula in Calorie Intake, Nutritional Status, and Clinical Outcomes Among Infants Who Underwent Congenital Heart Disease Surgery: A Randomized, Double-blind Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 14, 2018 (Actual)
Primary Completion Date
November 3, 2019 (Actual)
Study Completion Date
February 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cardiovascular Center Harapan Kita Hospital Indonesia
Collaborators
Danone Institute International
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
Is there any difference in nutritional status between both groups after 3 months?
Is there any difference in calorie intake per day between both groups during hospitalization?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease in Children, Malnutrition, Child
Keywords
anthropometry, congenital heart disease, infant formula, nutritional status, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
High-calorie density formula (1 kcal/ml)
Arm Title
Control arm
Arm Type
Placebo Comparator
Arm Description
Standard formula (0.67 kcal/ml)
Intervention Type
Dietary Supplement
Intervention Name(s)
High-calorie density formula (1 kcal/ml)
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard formula (0.67 kcal/ml)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Nutritional status
Description
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
Secondary Outcome Measure Information:
Title
Calorie intake
Description
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
Title
Weight
Description
Numeric data of absolute weight (kg)
Time Frame
After 1, 2, and 3 months of intervention
Title
Length
Description
Numeric data of absolute length (cm)
Time Frame
After 1, 2, and 3 months of intervention
Title
Weight-for-age z-score changes
Description
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
Title
Length-for-age z-score changes
Description
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
Title
Weight-for-length z-score changes
Description
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
Title
Malnutrition risk
Description
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
Title
Mortality
Description
The event proportion of mortality (%)
Time Frame
Through study completion, an average of 3 months
Title
Duration of mechanical ventilation
Description
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
Title
Length of stay
Description
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
Title
Side effects
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Days
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reni Fitriasari, MD
Organizational Affiliation
National Cardiovascular Center Harapan Kita
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cardiovascular Center Harapan Kita
City
Jakarta
ZIP/Postal Code
11420
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of High-Calorie Formula on Nutritional and Clinical Outcomes Among Infants After Congenital Heart Surgery
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