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ClinicalTrials.gov ID

NCT07552688

Lead Sponsor

Aryan Najmadin NasradinOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

75Estimated

Last Update Posted

Apr 29, 2026Actual

Start Date

Apr 17, 2026Estimated

Primary Completion Date

Jun 1, 2026Estimated

Completion Date

Jun 1, 2026Estimated

Official Title

"Effects of High-Calorie Diet vs High-Calorie Formula on Weight Gain and Clinical Outcomes Among Children With Congenital Heart Disease"

Brief 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.

Detailed 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.

• Weight Gain
• Body Mass Index
• Pediatric Nutrition
• Congenital Heart Disease
• Undernutrition

• High-Calorie Specialized Nutritional Formula
• education program
• High-Calorie Diet

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Aryan Najmadin NasradinOTHER

nursing@hum.edu.krd07500166362