"Effects of High-Calorie Diet vs High-Calorie Formula on Weight Gain and Clinical Outcomes Among Children With Congenital Heart Disease: A Randomized Controlled Trial"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Mean weight gain (kg) from baseline to 8 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
High-Calorie Diet Group
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.
干预措施: education program (Behavioral)
High-Calorie Diet Group
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.
干预措施: High-Calorie Diet (Dietary Supplement)
High-Calorie Diet + Specialized Formula Group
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.
干预措施: High-Calorie Specialized Nutritional Formula (Dietary Supplement)
High-Calorie Diet + Specialized Formula Group
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.
干预措施: education program (Behavioral)
Control Group - Standard Diet (No Intervention) Group
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.
结局指标
主要结局
Mean weight gain (kg) from baseline to 8 weeks
时间窗: 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.
次要结局
- Parental Knowledge Improvement(Measured at baseline and at week 8.)
- Feeding Tolerance(Monitored weekly throughout the 8-week intervention.)
研究者
Aryan Najmadin Nasradin
MSc student
Hawler Medical University