- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03453502
Improving Mother Milk Feeding Benefits in Neonatal Intensive Care Units
October 29, 2021 updated by: Zhangbin Yu, Nanjing Medical University
Improving Mother Milk Feeding Benefits in Neonatal Intensive Care Units Using the Evidence-based Practice for Quality Improvement
Twenty-seven hospitals in China will participate in the study, which aims to increase breastfeeding rate in the neonatal intensive care unit (NICU) and reduce the clinical complications in very low birth weight infants and extremely low birth weight infants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Breast milk reduces the risk of serious prematurity related morbidities.
Quality improvement is an effective means of increasing breast milk feeding.Twenty-seven hospitals in China will participate in the study, which aims to increase breastfeeding rate in the NICU and reduce the clinical complications in very low birth weight infants and extremely low birth weight infants.
This study compared the clinical data of very low birth weight infants and extremely low birth weight infants in three phases:Before-intervention phase,Intervention phase and Sustainability phase.
During the Intervention phase and Sustainability phase multiple intervention bundles of quality improvement were implemented.The investigators will compare breast milk feeding rate and neonatal outcomes in different phases.
Study Type
Interventional
Enrollment (Anticipated)
1800
Phase
- Not Applicable
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:
- premature Infants (Birth weight<1500g)
Exclusion Criteria:
- mother with sever illness or communicable disease
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: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Before-intervention phase
All the very low birth weight (VLBW) and extremely low birth weight (ELBW) infants who were admitted from January 2017 to December 2017 to the NICUs of different hospitals.
|
|
EXPERIMENTAL: Intervention phase
All the VLBW and ELBW infants who were admitted from January 2018 to December 2018 to the NICUs.During this phase,multiple intervention bundles of quality improvement will be implemented.
|
During the Intervention phase and Sustainability phase ,The NICUs will receive training of multiple evidence based quality improvement methods.
|
EXPERIMENTAL: Sustainability intervention phase
All the VLBW and ELBW infants who were admitted from January 2019 to December 2019to the NICUs.In the Sustainability intervention phase,multiple intervention bundles of quality improvement will be continuous implemented.
|
During the Intervention phase and Sustainability phase ,The NICUs will receive training of multiple evidence based quality improvement methods.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mother own milk feeding rates
Time Frame: three years
|
three years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NICU costs
Time Frame: three years
|
costs during hospitalization in NICU
|
three years
|
the incidence of necrotizing enterocolitis (NEC)
Time Frame: three years
|
the incidence of necrotizing enterocolitis
|
three years
|
the incidence of sepsis
Time Frame: three years
|
three years
|
|
Reduce the incidence of enteral feed intolerance
Time Frame: three years
|
three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Zhangbin Yu, PhD, Nanjing Maternity and Child Health Care Hospital
- Principal Investigator: Jun Zhang, PhD, Nanjing Maternity and Child Health Care Hospital
- Principal Investigator: Yuhua Hu, PhD, Jiangsu Women and Children Health Hospital
- Principal Investigator: Shan Li, PhD, The First People's Hospital of Lianyungang
- Principal Investigator: Xiaoyi Deng, PhD, Xuzhou Maternity and Child Health Care Hospital
- Principal Investigator: Zelin Jiao, PhD, The Second Hospital of Nanjing Medical University
- Principal Investigator: Rui Cheng, PhD, Children's Hospital of Nanjing Medical University
- Principal Investigator: Weiyuan Wang, PhD, Suqian Maternity and Child Health Care Hospital
- Principal Investigator: Yan Gao, PhD, Lianyungang Maternity and Child Health Care Hospital
- Principal Investigator: Zhengying Li, PhD, Wuxi Women's & Children's Hospital
- Principal Investigator: Sannan Wang, PhD, Suzhou Municipal Hospital
- Principal Investigator: Jinlan Chai, PhD, Yancheng Maternity and Child Health Care Hospital
- Principal Investigator: Zhun xu, PhD, The First People's Hospital of Yancheng
- Principal Investigator: Jun Wan, PhD, The Affiliated Jiangyin Hospital of Southeast University Medical College
- Principal Investigator: Weidong xu, PhD, The First People's Hospital of Zhangjiagang
- Principal Investigator: Zhaofang Tian, PhD, The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University
- Principal Investigator: Liangrong Han, PhD, Huaian Maternity and Child Health Care Hospital
- Principal Investigator: Jinxiu Wang, PhD, Changzhou Maternal and Child Care Hospital
- Principal Investigator: Xuqin Mao, PhD, Zhenjiang Maternity and Child Health Care Hospital
- Principal Investigator: Jun Wang, PhD, The Affiliated Hospital of Xuzhou Medical University
- Principal Investigator: Mei Xue, PhD, Taizhou People's Hospital
- Principal Investigator: Hongyan Lu, PhD, Affiliated Hospital of Jiangsu University
- Principal Investigator: Mingfu Wu, PhD, First People's Hospital of Hangzhou
- Principal Investigator: Qin Zhou, PhD, Wuxi Maternity and Child Health Care Hospital
- Principal Investigator: Wenjuan Tu, PhD, Changzhou Children's Hospital
- Principal Investigator: Lingling Zhu, PhD, Northern Jiangsu Province People's Hospital
- Principal Investigator: Bin Sun, PhD, Children's Hospital of Soochow University
- Principal Investigator: Shuangshuang Li, PhD, Nantong Maternity and Child Health Care Hospital
- Principal Investigator: Xiaohui Chen, PhD, Nanjing Maternity and Child Health 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)
January 1, 2017
Primary Completion (ACTUAL)
December 31, 2019
Study Completion (ACTUAL)
December 31, 2019
Study Registration Dates
First Submitted
February 27, 2018
First Submitted That Met QC Criteria
March 2, 2018
First Posted (ACTUAL)
March 5, 2018
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
Keywords
Other Study ID Numbers
- NMU-FY2017-350
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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