The Effect of High-Calorie Formula on Nutritional and Clinical Outcomes Among Infants After Conge… (NCT05945459) | Clinical Trial Compass
CompletedNot Applicable
The Effect of High-Calorie Formula on Nutritional and Clinical Outcomes Among Infants After Congenital Heart Surgery
Indonesia158 participantsStarted 2018-02-14
Plain-language 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.
Who can participate
Age range
14 Days – 1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Nutritional status
Timeframe: After 3 months of intervention
Trial details
NCT IDNCT05945459
SponsorNational Cardiovascular Center Harapan Kita Hospital Indonesia