Effectiveness of High-Energy Density Enteral Nutrition for Enhancing Physical Growth and Cognitive Brain Development in Infants With Congenital Heart Disease: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Weight-for-age z score (WAZ)
研究概览
简要总结
The purpose of this study is to compare the effect of high and ordinary energy density enteral nutrition for improving physical growth and brain cognitive development in infants with congenital heart disease after operation, as well as evaluate the safety of interventions.
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
入排标准
- 年龄范围
- 0 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with congenital heart disease through symptoms, physical signs, imaging, and ultrasound examinations.
- •Age 0-6 months
- •Children with nutritional risks (defined by STRONGkids: Nutritional risk screening tool for children )
- •Artificial or mixed feeding
- •Open heart surgery under cardiopulmonary bypass
- •The guardians of the children voluntarily participate in this study and sign a written informed consent form before the surgery.
排除标准
- •Diagnosed with major non cardiac diseases leading to nutritional intake disorders, such as congenital gastrointestinal malformations, preoperative diagnosis of gastroesophageal reflux, genetic diseases related to growth restriction, and various syndromes with chromosomal abnormalities (trisomy 21 syndrome, trisomy 18 syndrome)
- •Abnormal immune system function due to congenital or acquired factors, unable to effectively resist pathogens or eliminate abnormal cells, which can be divided into primary and secondary immunodeficiencies.
- •Any pre - operative history of neurological diseases (e.g., encephalitis, epilepsy).
- •Secondary or primary gastrointestinal infection symptoms such as abdominal distension and diarrhea after surgery.
- •Estimated stay time in the postoperative intensive care unit ≤ 2 days
研究组 & 干预措施
High energy density enteral nutrition
High-energy-density enteral nutrition (100 cal/100 ml) will be administered to infants following surgery for congenital heart disease. The target feeding volume will be determined based on the infant's body weight (80-100 ml/kg), with the volume per feeding and frequency appropriately adjusted. Weight measurements and neurological assessments will be conducted at admission, prior to discharge, and at 1-, 3-, and 6-month intervals post-discharge. The safety of the intervention will be closely monitored throughout the study period.
干预措施: High energy density enteral nutrition (Dietary Supplement)
General energy density enteral nutrition
General energy density enteral nutrition (60-88cal/100 ml) will be administered to infants following surgery for congenital heart disease. The target feeding volume will be determined based on the infant's body weight (80-100 ml/kg), with the volume per feeding and frequency appropriately adjusted. Weight measurements and neurological assessments will be conducted at admission, prior to discharge, and at 1-, 3-, and 6-month intervals post-discharge. The safety of the intervention will be closely monitored throughout the study period.
干预措施: General energy density enteral nutrition (Dietary Supplement)
结局指标
主要结局
Weight-for-age z score (WAZ)
时间窗: 6th month after discharge
WAZ is calculated according to the Chinese child growth curve and cut-offs .It is a statistical index used to assess the nutritional status of children. The physical examination will be conducted by a nurse, and the data will be recorded to one decimal place.
次要结局
- Weight-for-age z score (WAZ)(Before discharge, 1st month, 3rd month after discharge)
- Albumin level(Before discharge, 1 month, 3 months, 6 months after discharge)
- Energy intake (cal/d)(During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge)
- Incidence of malabsorption(During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge)
- Cognitive development(Before discharge, 1st month, 3rd month, 6th month after discharge)
- Blood lipid levels(Before discharge, 1 month, 3 months, 6 months after discharge)
- Incidence of subjects with Gastrointestinal mucosal barrier function injury(Before discharge, 1 month, 3 months, 6 months after discharge)
- Incidence of feeding intolerance(During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge)
- Enteral Nutrition intake (ml/d)(During hospitalization, before discharge, 1 month, 3 months, 6 months after discharge)
- Incidence of necrotizing enterocolitis（NEC）(Before discharge, 1 month, 3 months, 6 months after discharge)
- Other surgical indications(At the day of discharge, an average of 3 week after surgery)