To Improve the Rate of Mother's Own Milk Feeding of Premature Infants in NICU
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention group 6 NICUs in the intervention group . The participating units of the intervention group determine the improvement items (one or more) in each quarter from the list of best practices of breast feeding quality improvement of Jiangsu Province, and report the improvement plan to the supervision unit, and recommend the application of PDSA (plan-do-study-act) for the implementation of quality improvement loop. Report the implementation of quality improvement to the supervision unit on a quarterly basis. |
Behavioral: Experimental: Intervention group
The intervention NICUs (n = 6) will receive training in the Evidence-based Practice for Improving Quality (EPIQ) method and then develop, implement, and document evidence-based practice changes toimprove the rate of breastfeeding . Compliance with practice changes and neonatal outcomes will be monitored. NICUs will receive quarterly feedback on their progress, as well as access to implementation support.
|
| No Intervention: control group Continue current practices |
Outcome Measures
Primary Outcome Measures
- exclusive breastfeeding rate 24 hours before discharge [two years]
exclusive breastfeeding rate 24 hours before discharge
Secondary Outcome Measures
- Time of Mother's Own Milk at starting feed（hours） [two years]
Time of Mother's Own Milk at starting feed（hours）
- Proportion of first time Mother's Own Milk (%) [two years]
Proportion of first time Mother's Own Milk (%)
- Duration of parenteral nutrition (days) [two years]
Duration of parenteral nutrition (days)
- Time to total gastrointestinal feeding (days) [two years]
Time to total gastrointestinal feeding (days)
- Pump milk times (times /d) and amount (ml / d) ：1-3d, 4-7d ,8-14d [two years]
Pump milk times (times /d) and amount (ml / d) ：1-3d, 4-7d ,8-14d
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Weight less than 1500g or gestational age less than 32 weeks;
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Admission to NICU.
Exclusion Criteria:
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Pregnancy with serious diseases, infectious diseases or other medical contraindications for breast-feeding (such as galactosemia);
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infants did not survive were excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nanjing Maternity and Child Health Care Hospital | Nanjing | Jiangsu | China | 210004 |
Sponsors and Collaborators
- Nanjing Medical University
- Nanjing Maternity and Child Health Care Hospital
- Jiangsu Maternity and Child Health Care Hospital
- Xuzhou Maternity and Child Health Care Hospital
- Affiliated Hospital of Jiangsu University
- Yangzhou Maternity and Child Health Care Hospital
- Lianyungang Maternity and Child Health Care Hospital
- Nantong Maternity and Child Health Care Hospital
- The First People's Hospital of Jiangyin
- Yangzhou No.1 People's Hospital
- Subei people's Hospital
- Wuxi Maternity and Child Health Care Hospital
- The Affiliated Hospital of Xuzhou Medical University
- Changzhou Maternal and Child Care Hospital
Investigators
- Study Director: Han Shuping, PhD, Nanjing Maternity and Child Health Care Hospital
- Study Director: Yu Zhangbin, PhD, Nanjing Maternity and Child Health Care Hospital
- Principal Investigator: Chen Xiaoqing, PhD, Jiangsu Maternity and Child Health Care Hospital
- Principal Investigator: Deng Xiaoyi, PhD, Xuzhou Maternity and Child Health Care Hospital
- Principal Investigator: Lu Hongyan, PhD, Affiliated Hospital of Jiangsu University
- Principal Investigator: Wu Xinping, PhD, Yangzhou Maternity and Child Health Care Hospital
- Principal Investigator: Gao Yan, PhD, Lianyungang Maternity and Child Health Care Hospital
- Principal Investigator: Li Shuangshuang, PhD, Nantong Maternity and Child Health Care Hospital
- Principal Investigator: Wan Jun, PhD, The First People's Hospital of Jiangyin
- Principal Investigator: Wu Mingfu, PhD, Yangzhou No.1 People's Hospital
- Principal Investigator: Zhu Lingling, PhD, Subei people's Hospital
- Principal Investigator: Zhou Qin, PhD, Wuxi Maternity and Child Health Care Hospital
- Principal Investigator: Wang Jun, PhD, The Affiliated Hospital of Xuzhou Medical University
- Principal Investigator: Wang Huaiyan, PhD, Changzhou Maternal and Child Care Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NMU-FY2016-73