The Effect of Time to Start Breast Milk Fortifiers on Neonatal Outcomes in Very Low Birth Weight Premature Infants.
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- The effect of time to start breast milk fortifiers on full enteral feeding day.
研究概览
简要总结
In the study, very low birth weight babies born in our hospital will be randomized in the closed envelope method, and breast milk fortifier will be started when 50 ml/kg/day breastfeeding volume is reached in one group, and breast milk enrichment will be started when 100 ml/kg/day enteral feeding is reached in the other group. In the study, the babies in these two groups will be compared by making early (nutrition characteristics and premature morbidity) and long-term follow-ups. In this study, a 30% reduction in the transition time to full enteral nutrition between the groups corresponds to a difference of approximately 5 days. In our study, the sample size was determined as at least 78 patients in each group, with a margin of error of 0.05 and a power of 80% to show the 5-day difference between the groups.
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
- Single (Care Provider)
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm babies born weighing less than 1500 grams
排除标准
- •Babies with congenital anomalies
- •Infants who develop necrotizing enterocolitis or spontaneous intestinal perforation before starting a breast milk fortifier
- •Babies lost before reaching 50 cc/kg enteral nutrition
- •Babies who are not breastfed
结局指标
主要结局
The effect of time to start breast milk fortifiers on full enteral feeding day.
时间窗: 1 year
In this study, a 30% reduction in transition time to full enteral nutrition between the groups corresponds to a difference of approximately 5 days. In the study, the sample size was determined as at least 78 patients in each group, with a margin of error of 0.05 and a power of 80% to show the 5-day difference between the groups.
次要结局
- Time to discharge (days)(1 year)
- Weight gain rate (grams/day)(1 year)
- Duration of parenteral nutrition (days)(1 year)