- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04383379
To Improve the Rate of Mother's Own Milk Feeding of Premature Infants in NICU
October 29, 2021 updated by: Zhangbin Yu, Nanjing Medical University
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
1500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yu Zhangbin, PhD
- Phone Number: +86-025-52226567
- Email: zhangbinyu@njmu.edu.cn
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210004
- Recruiting
- Nanjing Maternity and Child Health Care Hospital
-
Contact:
- Yu Zhangbin, PhD
- Phone Number: +86-025-52226567
- Email: zhangbinyu@njmu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 3 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Weight less than 1500g or gestational age less than 32 weeks;
- Admission to NICU.
Exclusion Criteria:
- Pregnancy with serious diseases, infectious diseases or other medical contraindications for breast-feeding (such as galactosemia);
- infants did not survive were excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
exclusive breastfeeding rate 24 hours before discharge
Time Frame: two years
|
exclusive breastfeeding rate 24 hours before discharge
|
two years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time of Mother's Own Milk at starting feed(hours)
Time Frame: two years
|
Time of Mother's Own Milk at starting feed(hours)
|
two years
|
Proportion of first time Mother's Own Milk (%)
Time Frame: two years
|
Proportion of first time Mother's Own Milk (%)
|
two years
|
Duration of parenteral nutrition (days)
Time Frame: two years
|
Duration of parenteral nutrition (days)
|
two years
|
Time to total gastrointestinal feeding (days)
Time Frame: two years
|
Time to total gastrointestinal feeding (days)
|
two years
|
Pump milk times (times /d) and amount (ml / d) :1-3d, 4-7d ,8-14d
Time Frame: two years
|
Pump milk times (times /d) and amount (ml / d) :1-3d, 4-7d ,8-14d
|
two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2020
Primary Completion (Anticipated)
April 30, 2022
Study Completion (Anticipated)
April 30, 2022
Study Registration Dates
First Submitted
May 7, 2020
First Submitted That Met QC Criteria
May 7, 2020
First Posted (Actual)
May 12, 2020
Study Record Updates
Last Update Posted (Actual)
November 1, 2021
Last Update Submitted That Met QC Criteria
October 29, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMU-FY2016-73
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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