Body Mass Index, Congenital Heart Disease, Pediatric Nutrition, Undernutrition, Weight Gain
Conditions
Keywords
BMI, Nutritional Status, Growth and Development, Pediatric Nursing
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.
Interventions
DIETARY_SUPPLEMENTHigh-Calorie Specialized Nutritional Formula
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.
BEHAVIORALeducation program
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.
DIETARY_SUPPLEMENTHigh-Calorie Diet
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.
Sponsors
Aryan Najmadin Nasradin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This study is open-label, meaning that both the participants (children and their caregivers) and the researcher are aware of the dietary intervention assigned. Due to the nature of nutritional interventions-different diets and formulas-blinding is not feasible. All outcomes will be assessed objectively to minimize bias.
Intervention model description
articipants will be randomly assigned to one of three groups. Each group will receive a different dietary intervention: a standard diet, a high-calorie diet made with natural energy-dense foods, or a high-calorie diet combined with a specialized pediatric formula. All groups will be followed simultaneously over an 8-week period to compare the effects of these interventions on weight gain and clinical outcomes.
Eligibility
Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean weight gain (kg) from baseline to 8 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Parental Knowledge Improvement | 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. |
Countries
Iraq
Contacts
CONTACTaryan najmadin, B.Sc nursing
CONTACTDr.nazar Ramadhan, assist prof
PRINCIPAL_INVESTIGATORaryan najmadin, BSc
Hawler Medical University
STUDY_DIRECTORnazar ramadhan, assist prof
hawler medical university college of nursing
Outcome results
None listed