Effect of a High Density Formula on Growth and Safety in Early Postoperative Infants With Congenital Heart Disease Duration of Cardiac Intensive Care Unit（CCU）Stay: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- weight gain at the 7th day (g)
研究概览
简要总结
The purpose of this study is to explore the effects of high density formula in early postoperative infants with congenital heart disease and to assess its safety.
详细描述
The number of infants born with CHD increases every year and most CHD infants are suffered with malnutrition.Recent studies have shown that increasing energy intake in CHD infants can improve their nutrition status.But there are no high qualified evidences supporting that high density formula can promote infants' nutrition status and ensure its safety. The hypothesis of the current study is that high density formula intake can increase infants'weight and it's safe.
The current study adopts randomized,controlled intervention trial, gives high density formula(Infatrini,100kcal/100ml)to CHD infants in intervention group and normal density formula（Neocate,67kcal/100ml）in control group. Intervention begins when infants start enteral nutrition after operation and continues for 7days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of congenital heart disease from symptoms, signs, ultrasonic and imaging examination
- •aged from 1 day to 12 months
- •accept extracorporeal circulation open-heart surgery
- •family members voluntarily participate in this study
排除标准
- •patients have other diseases which cause nutrition disorders, such as gastrointestinal malformation, preoperative gastroesophageal reflux, genetic diseases related to the growth restriction
- •accept total parenteral nutrition
- •predicted the length of CCU stay is less than five days
- •patients have abdominal distention, diarrhea, vomiting
结局指标
主要结局
weight gain at the 7th day (g)
时间窗: from the first day starting enteric feeding to the 7th days
the 7th day body weight minus baseline body weight
the number of participants with feeding intolerance
时间窗: from the first day starting enteric feeding to the 7th day
Feeding intolerance means participants have gastric retention, vomiting, diarrhea ect. lead to enteric feeding was stopped.
次要结局
- the number of participants with poor wound healing(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Duration of mechanical ventilation(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- length of Cardiac Intensive Care Unit(CCU) stay(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- the number of participants with necrotizing enterocolitis(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)