Congenital Heart Disease in ChildrenNCT05945459
The Effect of High-Calorie Formula on Nutritional and Clinical Outcomes Among Infants After Congenital Heart Surgery
A study testing High-calorie density formula (1 kcal/ml) and Standard formula (0.67 kcal/ml) in people with Congenital Heart Disease in Children and Malnutrition, Child, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 days to 1 year
- Conditions the study is for
- Congenital Heart Disease in Children, Malnutrition, Child
- What is being tested?
- High-calorie density formula (1 kcal/ml) and Standard formula (0.67 kcal/ml)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteIndonesia
- Study dates
- 14 Feb 2018to 15 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 days to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- History of prematurity (<37 weeks gestational age)
- Formula intolerance or cow milk protein allergy
- Lethal chromosome abnormality
- Galactosemia
- Gastrointestinal malformation or obstruction
- Renal failure
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- High-calorie density formula (1 kcal/ml), Standard formula (0.67 kcal/ml)
- Keywords
- anthropometry, congenital heart disease, infant formula, nutritional status, randomized controlled trial
- Medical subject headings
- Child Nutrition Disorders, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | High-calorie density formula (1 kcal/ml) Receives: Dietary Supplement: High-calorie density formula (1 kcal/ml) |
| Control arm | Placebo comparator | Standard formula (0.67 kcal/ml) Receives: Dietary Supplement: Standard formula (0.67 kcal/ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After 3 months of intervention
Secondary outcomes (11)
Calorie intake
Numeric data of the infants' total calorie intake (kcal/kg/day) during hospitalization
Measured: From the date of randomization to the date of discharge, assessed up to 3 months
Weight
Numeric data of absolute weight (kg)
Measured: After 1, 2, and 3 months of intervention
Length
Numeric data of absolute length (cm)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: After 1, 2, and 3 months of intervention
Mortality
The event proportion of mortality (%)
Measured: Through study completion, an average of 3 months
Duration of mechanical ventilation
The difference of mechanical ventilation duration (hours)
Measured: 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)
Measured: 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
Measured: From the date of randomization to the date of hospital discharge, assessed up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start14 Feb 2018
- Primary completion3 Nov 2019
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Institute International
- Responsible party
- Principal investigator, Eva M Marwali,MD, National Cardiovascular Center Harapan Kita Hospital Indonesia
- Investigators
- Reni Fitriasari, MD, Principal investigator, National Cardiovascular Center Harapan Kita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945459
- Sponsor's protocol ID
- LB.02.01/VII/214/KEP.036/2017
- Status last verified
- Jul 2023
- First submitted
- 14 Jun 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05945459
- Acronym / sponsor ID
- LB.02.01/VII/214/KEP.036/2017
- Keywords
- anthropometry, congenital heart disease, infant formula, nutritional status, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital IndonesiaUniversity, hospital or other
- Collaborators
- Danone Institute International
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 3 Nov 2019 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Dietary Supplement: High-calorie density formula (1 kcal/ml)High-calorie density formula (1 kcal/ml) |
| Control arm | Placebo comparator | Dietary Supplement: Standard formula (0.67 kcal/ml)Standard formula (0.67 kcal/ml) |
Who may qualify
- Ages
- 14 days to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- History of prematurity (<37 weeks gestational age)
- Formula intolerance or cow milk protein allergy
- Lethal chromosome abnormality
- Galactosemia
- Gastrointestinal malformation or obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-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 supplement | Intervention arm |
| Standard 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). | Dietary supplement | Control arm |
Primary outcome
Nutritional status
Time frame: 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
11 secondary outcomes
Calorie intake
Time frame: From the date of randomization to the date of discharge, assessed up to 3 months
Weight
Time frame: After 1, 2, and 3 months of intervention
Length
Time frame: After 1, 2, and 3 months of intervention
Weight-for-age z-score changes
Time frame: From the date of randomization to after 1, 2, and 3 months of intervention
Length-for-age z-score changes
Time frame: From the date of randomization to after 1, 2, and 3 months of intervention
Weight-for-length z-score changes
Time frame: From the date of randomization to after 1, 2, and 3 months of intervention
Malnutrition risk
Time frame: After 1, 2, and 3 months of intervention
Mortality
Time frame: Through study completion, an average of 3 months
Duration of mechanical ventilation
Time frame: From the date of randomization to the date of hospital discharge, assessed up to 3 months
Length of stay
Time frame: From the date of randomization to the date of discharge, assessed up to 3 months
Side effects
Time frame: From the date of randomization to the date of hospital discharge, assessed up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reni Fitriasari, MD principal investigator
National Cardiovascular Center Harapan Kita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-calorie density formula (1 kcal/ml) and Standard formula (0.67 kcal/ml) in people with Congenital Heart Disease in Children and Malnutrition, Child, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional status (time frame: After 3 months of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.