Evidence-Based Practice for Improving Quality(EPIQ) to Improve the Rate of Mother's Own Milk Feeding of Premature Infants in NICU: Study Protocol for a Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- exclusive breastfeeding rate 24 hours before discharge
研究概览
简要总结
Thirteen hospitals in China will participate in the study, which objectives of this study is to improve the rate of mother's own milk feeding of premature infants in neonatal intensive care unit(NICU), evaluate the effectiveness of improving the quality of breastfeeding in clinical use ,form standardized process and improve clinical medical quality of premature infants.
详细描述
In this study, the cluster randomized controlled matching design was used. Considering that evidence-based practice for improving quality(EPIQ) method is not only to improve the quality of individual, but also to improve the quality of breast-feeding of the whole neonatal intensive care unit(NICU), so a hospital was chosen as a cluster. The supervision unit is used for the quality control , coordination and technical support in the whole study process.The two NICU with similar number of premature infants, the same scale of NICU and little difference in the recognition of breast-feeding quality improvement measures that meet the inclusion criteria are taken as the a floor, and then randomly divided into two groups, taking the NICU as intervention group or the control group can avoid the individual influence of the intervention. In this study, recruited 12 NICUs. The purpose of study is to to increase the consumption of mother's own milk of premature infants through the existing measures of improving the breastfeeding quality, and then to improve the quality of life of the premature infant, and to further evaluate whether this model of improving the breastfeeding quality can be promoted in other NICU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- — 至 120 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight less than 1500g or gestational age less than 32 weeks;
- •Admission to NICU.
排除标准
- •Pregnancy with serious diseases, infectious diseases or other medical contraindications for breast-feeding (such as galactosemia);
- •infants did not survive were excluded.
结局指标
主要结局
exclusive breastfeeding rate 24 hours before discharge
时间窗: two years
exclusive breastfeeding rate 24 hours before discharge
次要结局
- Time to total gastrointestinal feeding (days)(two years)
- Time of Mother's Own Milk at starting feed（hours）(two years)
- Proportion of first time Mother's Own Milk (%)(two years)
- Duration of parenteral nutrition (days)(two years)
- Pump milk times (times /d) and amount (ml / d) ：1-3d, 4-7d ,8-14d(two years)
研究者
Zhangbin Yu
Principal Investigator of Nan Jing Maternity and Child Health Care Hospital
Nanjing Medical University