"Effects of High-Calorie Diets VS High-Calorie Formulas on Weight Gain in Children With Congenita… (NCT07552688) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
"Effects of High-Calorie Diets VS High-Calorie Formulas on Weight Gain in Children With Congenital Heart Disease "
Iraq75 participantsStarted 2026-04-17
Plain-language summary
This study is a randomized controlled trial designed to evaluate the effects of high-calorie diets and specialized nutritional formulas on weight gain and clinical outcomes in underweight children aged 1 to 5 years with congenital heart disease (CHD). Children with CHD often experience growth failure due to increased energy needs and feeding difficulties, which can negatively impact their recovery, development, and overall health.
Seventy-five children will be randomly assigned to one of three groups: a control group receiving a standard diet, a group receiving a high-calorie diet made from energy-dense foods, and a third group receiving both the high-calorie diet and a specialized high-calorie pediatric formula. The study will measure changes in weight, appetite, feeding tolerance, and other growth indicators over an 8-week period. The goal is to determine whether enhanced nutritional support can improve weight gain and health outcomes in this high-risk population.
Who can participate
Age range
1 Year – 5 Years
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:
* Children aged 1 to 5 years.
* Diagnosed with congenital heart disease (confirmed by echocardiography).
* Underweight (weight-for-age below the 10th percentile).
* Medically stable and eligible for oral or enteral feeding.
* Informed consent obtained from a parent.
Exclusion Criteria:
* Children with genetic syndromes known to affect growth (e.g., Down syndrome).
* Children with gastrointestinal conditions impairing nutrient absorption.
* Children who had cardiac surgery within the last 4 weeks.
* Presence of severe organ failure (renal, hepatic, etc.).
* Children on parenteral nutrition.
* Families unlikely to adhere to follow-up or dietary instructions.
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
Mean weight gain (kg) from baseline to 8 weeks
Timeframe: From baseline (week 0) to week 8 after the start of the dietary intervention.