The Effect of High-calorie Density Formula Versus Standard Formula in Calorie Intake, Nutritional Status, and Clinical Outcomes Among Infants Who Underwent Congenital Heart Disease Surgery: A Randomized, Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Nutritional status
研究概览
简要总结
The goal of this clinical trial is to compare the effect of high-calorie density formula (HDF) and standard formula (SF) in infants with congenital heart surgery. The main questions it aims to answer are:
- Is there any difference in nutritional status between both groups after 3 months?
- Is there any difference in calorie intake per day between both groups during hospitalization?
- Is there any difference in clinical outcomes (mortality, duration of using mechanical ventilation, length of stay, and events of side effects) between both groups?
A group of participants will be given HDF (1 kcal/ml) from enrollment until three months. Researchers will compare them to the group of participants who are given SF (0.67 kcal/ml) to see if there is any difference in nutritional status, calorie intake, and other clinical outcomes between the two groups.
详细描述
The study is a randomized, double-blind controlled trial to compare the efficacy of HDF formula compared to SF in nutritional and clinical outcomes among infants who had congenital heart surgery in Harapan Kita National Cardiovascular Centre (HKNCC), Jakarta, Indonesia.
The researchers use consecutive sampling to include eligible infants and obtain informed consent from the parent or legal guardian of infants who fulfilled the eligibility criteria. Block randomization is done by a research assistant, and then the allocation is prepared using a sealed envelope to assign infants into HDF and SF groups.
Participants are then assessed by a multi-professional team and given enteral feeds based on local guidelines. Routine follow-up is done at 2 weeks, 1 month, 2 months, and 3 months after the intervention to record weight, length, and any episode of complication or adverse events.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Days 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient of less than 1 year of age who underwent congenital heart surgery procedure in Harapan Kita National Cardiovascular Center
- •Risk adjustment for congenital heart surgery (RACHS) score 2-4
- •Patients who do not get exclusive breastfeeding due to any cause
排除标准
- •History of prematurity (<37 weeks gestational age)
- •Formula intolerance or cow milk protein allergy
- •Lethal chromosome abnormality
- •Galactosemia
- •Gastrointestinal malformation or obstruction
- •Renal failure
- •Liver disease
- •Metabolic abnormalities
- •Need for extracorporeal membrane oxygenation
- •Patients who develop diarrhea for more than 5 days during the study period despite getting adequate therapy
- •Patients who need prolonged total parenteral nutrition (e.g., gastrointestinal bleeding due to any cause, chylothorax, etc.)
- •Patients with necrotizing enterocolitis during the study period
结局指标
主要结局
Nutritional status
时间窗: After 3 months of intervention
Numeric data of weight-for-length z-score (WLZ), length-for-age z-score (LAZ) and weight-for-age z-score (WAZ) based on the 2006 World Health Organization (WHO) Child Growth Standard
次要结局
- Weight(After 1, 2, and 3 months of intervention)
- Length(After 1, 2, and 3 months of intervention)
- Calorie intake(From the date of randomization to the date of discharge, assessed up to 3 months)
- Malnutrition risk(After 1, 2, and 3 months of intervention)
- Mortality(Through study completion, an average of 3 months)
- Weight-for-age z-score changes(From the date of randomization to after 1, 2, and 3 months of intervention)
- Length-for-age z-score changes(From the date of randomization to after 1, 2, and 3 months of intervention)
- Weight-for-length z-score changes(From the date of randomization to after 1, 2, and 3 months of intervention)
- Duration of mechanical ventilation(From the date of randomization to the date of hospital discharge, assessed up to 3 months)
- Length of stay(From the date of randomization to the date of discharge, assessed up to 3 months)
- Side effects(From the date of randomization to the date of hospital discharge, assessed up to 3 months)
研究者
Eva M Marwali,MD
Principal Investigator
National Cardiovascular Center Harapan Kita Hospital Indonesia