"Effects of High-Calorie Diets VS High-Calorie Formulas on Weight Gain in Children With Congenital Heart Disease "

Starting soon · Not applicable

Conditions studied: Weight Gain, Body Mass Index, Pediatric Nutrition, Congenital Heart Disease, Undernutrition

In brief

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.

Key facts

Study ID

NCT07552688

Run by

Aryan Najmadin Nasradin

People needed

75

Starts

2026-04-17

Expected to finish

2026-06-01

Last updated by the study team

2026-04-29

Who can join

Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cardiac center Pediatric Cardiology Unit and Nutrition Clinic — Erbil, Iraq
• Pediatric Cardiology Unit, Cardiac Center — Erbil, Iraq

Full record on ClinicalTrials.gov

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