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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка High-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.
• Поведенческое education 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 feedi
• Пищевая добавка High-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 specia

Первичные конечные точки

• Mean weight gain (kg) from baseline to 8 weeks [Срок оценки: From baseline (week 0) to week 8 after the start of the dietary intervention.]

Вторичные конечные точки (1)

• Parental Knowledge Improvement [Срок оценки: Measured at baseline and at week 8.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Ирак · 2 центра

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

Идентификаторы

NCT: NCT07552688 · ANNasradin · U1111-1339-0340

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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