About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.).
Trial design
Treatments tested in this trial
- High-Calorie Specialized Nutritional Formula
- education program
- High-Calorie Diet
Treatment groups
Locations
2Sponsors and collaborators
Aryan Najmadin Nasradin
Lead sponsor
Hawler Medical University
Sponsor institution