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

Aryan Najmadin Nasradin

Status: Not yet enrolling

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

Treatments: Dietary Supplement: High-Calorie Specialized Nutritional Formula; Dietary Supplement: High-Calorie Diet; Behavioral: education program

Study type: Interventional

Funder types: Other

Identifiers

NCT07552688

ANNasradin

U1111-1339-0340 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Children with congenital heart disease (CHD) are at high risk of growth failure and malnutrition due to a combination of increased metabolic demands and feeding difficulties. Despite advancements in surgical and medical management, undernutrition remains a persistent challenge and can negatively affect recovery, development, and long-term health outcomes. While most nutritional intervention studies focus on infants or the immediate postoperative period, older children with CHD-particularly those aged 1 to 5 years-remain an understudied group, despite ongoing nutritional risks.

This study addresses a critical gap in pediatric cardiac care by evaluating whether targeted nutritional strategies, such as high-calorie diets and specialized pediatric formulas, can support better weight gain and overall health in this population. The intervention is designed to be practical and feasible, combining enriched natural foods and commercially available high-calorie formulas tailored to children with increased energy needs.

By comparing standard care with enhanced nutritional interventions over an 8-week period, this randomized controlled trial aims to provide evidence on effective, non-invasive nutritional approaches for improving the health and development of underweight children with CHD. The results are expected to inform clinical nutrition guidelines and support individualized care plans for pediatric cardiology patients.

Enrollment: 75 estimated patients

Sex: All

Ages: 1 to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

75 participants in 3 patient groups

High-Calorie Diet Group

Experimental group

Description:

Participants in this group will receive a diet enriched with additional calories through natural, energy-dense foods such as added oils, mashed avocados, and fortified cereals. The diet aims to exceed the child's estimated daily caloric needs to promote weight gain.

Treatment:

Behavioral: education program

Dietary Supplement: High-Calorie Diet

High-Calorie Diet + Specialized Formula Group

Experimental group

Description:

Participants in this group will receive the same high-calorie natural diet as Group 2, plus a commercially available specialized pediatric formula designed to meet increased energy and protein requirements in children with congenital heart disease. Formula amounts will be tailored to individual needs and tolerability.

Treatment:

Behavioral: education program

Dietary Supplement: High-Calorie Specialized Nutritional Formula

Control Group - Standard Diet (No Intervention) Group

No Intervention group

Description:

Participants receive a standard diet appropriate for their age and clinical condition, without any additional calorie enrichment or specialized formulas. This group serves as the baseline for comparison.