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| Name | Class |
|---|---|
| Nanjing Maternity and Child Health Care Hospital | OTHER |
| Jiangsu Maternity and Child Health Care Hospital | UNKNOWN |
| Xuzhou Maternity and Child Health Care Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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. |
|
| control group | No Intervention | Continue current practices |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Intervention group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| exclusive breastfeeding rate 24 hours before discharge | exclusive breastfeeding rate 24 hours before discharge | two years |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Mother's Own Milk at starting feed(hours) | Time of Mother's Own Milk at starting feed(hours) | two years |
| Proportion of first time Mother's Own Milk (%) | Proportion of first time Mother's Own Milk (%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Han Shuping, PhD | Contact | +86-025-52226561 | shupinghan@njmu.edu.cn | |
| Yu Zhangbin, PhD | Contact | +86-025-52226567 | zhangbinyu@njmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Han Shuping, PhD | Nanjing Maternity and Child Health Care Hospital | Study Director |
| Yu Zhangbin, PhD | Nanjing Maternity and Child Health Care Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Maternity and Child Health Care Hospital | Recruiting | Nanjing | Jiangsu | 210004 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34819117 | Derived | Huo J, Wu X, Gu C, Yu Z, Zhang J, Chen X, Zhu J, Liu F, Liu B, Li Q, Han S. Using a WeChat mini-program-based lactation consultant intervention to increase the consumption of mother's own milk by preterm infants in the neonatal intensive care unit: a study protocol for a cluster randomized controlled trial. Trials. 2021 Nov 24;22(1):834. doi: 10.1186/s13063-021-05731-6. |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
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| Affiliated Hospital of Jiangsu University |
| OTHER |
| Yangzhou Maternity and Child Health Care Hospital | UNKNOWN |
| Lianyungang Maternity and Child Health Care Hospital | UNKNOWN |
| Nantong Maternity and Child Health Care Hospital | UNKNOWN |
| The First People's Hospital of Jiangyin | UNKNOWN |
| Yangzhou No.1 People's Hospital | OTHER |
| Subei people's Hospital | UNKNOWN |
| Wuxi Maternity and Child Health Care Hospital | OTHER |
| The Affiliated Hospital of Xuzhou Medical University | OTHER |
| Changzhou Maternal and Child Care Hospital | OTHER |
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|
| two years |
| Duration of parenteral nutrition (days) | Duration of parenteral nutrition (days) | two years |
| Time to total gastrointestinal feeding (days) | Time to total gastrointestinal feeding (days) | two years |
| Pump milk times (times /d) and amount (ml / d) :1-3d, 4-7d ,8-14d | Pump milk times (times /d) and amount (ml / d) :1-3d, 4-7d ,8-14d | two years |
| 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 | Principal Investigator |
| D011248 |
| Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |