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NCT Number: NCT07552688

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

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.

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Key information

Conditions

Weight Gain Body Mass Index Body Weight Body Weight Changes Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Pediatric Nutrition Signs and Symptoms Undernutrition

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiac center Pediatric Cardiology Unit and Nutrition Clinic, Erbil, Iraq

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-Calorie Specialized Nutritional Formula

Dietary Supplement

This intervention involves providing a commercially available pediatric formula specially designed for children with congenital heart disease. The formula is enriched with additional calories and protein to meet the increased metabolic demands of this population. Intake volumes will be tailored to each child's caloric needs and feeding tolerance, with regular monitoring by a pediatric dietitian to ensure adherence and minimize gastrointestinal side effects.

Education program

Behavioral

This behavioral intervention consists of a structured education program aimed at primary caregivers of children aged 1-5 years with congenital heart disease (CHD) who are underweight. The program's goal is to improve caregivers' knowledge and practices related to child nutrition to promote healthy weight gain and growth.

The program includes six weekly sessions (45-60 minutes each) covering topics such as understanding CHD's impact on nutrition, age-appropriate dietary needs, high-calorie feeding strategies using home ingredients, safe use of specialized formulas, practical feeding techniques, and methods for monitoring progress.

Teaching methods involve lectures, group discussions, hands-on demonstrations, role-playing, visual aids, and provision of educational materials like meal plans, growth charts, and formula preparation guides. The intervention emphasizes practical skills and ongoing caregiver support to enhance feeding practices and child health outcomes.

Other names: Nutrition and Feeding Support Program for Children with Congenital Heart Disease (CHD)

High-Calorie Diet

Dietary Supplement

This intervention involves educating caregivers of children aged 1-5 years with congenital heart disease (CHD) on implementing a high-calorie diet to promote healthy weight gain and growth. Caregivers are taught how to prepare calorie-dense meals using commonly available home ingredients, including healthy fats, full-fat dairy, powdered milk, and nutrient-rich foods such as eggs, meat, and legumes.

The program includes practical guidance on meal enrichment, feeding schedules, safe use of specialized high-calorie formulas, and strategies to manage feeding difficulties. Caregivers receive tools such as recipe cards, sample meal plans, growth monitoring charts, and support through interactive sessions to ensure effective application of the diet.

Other names: High-Calorie Formula

Primary outcomes

  1. Mean weight gain (kg) from baseline to 8 weeks

    Time frame: From baseline (week 0) to week 8 after the start of the dietary intervention.

    Average change in body weight (in kilograms) from baseline (start of the study) to the end of the 8-week intervention period, measured using standardized calibrated scales.

Secondary outcomes

  1. Parental Knowledge Improvement

    Time frame: Measured at baseline and at week 8.

    Change in caregivers' knowledge about nutrition and feeding practices for children with CHD, assessed via pre- and post-intervention questionnaires.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr.nazar Ramadhan, assist prof

CONTACT

[email protected]

07504946398

aryan najmadin, B.Sc nursing

CONTACT

[email protected]

07501949549

Sponsors and collaborators

Lead sponsor

Aryan Najmadin Nasradin

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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