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To Improve the Rate of Mother's Own Milk Feeding of Premature Infants in NICU

Primary Purpose

Quality Improvement, Breast-feeding, Premature Infant

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Experimental: Intervention group
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Quality Improvement focused on measuring Quality Improvement, breast-feeding, premature infant, cluster randomized controlled

Eligibility Criteria

undefined - 120 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nanjing Maternity and Child Health Care HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

control group

Arm Description

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.

Continue current practices

Outcomes

Primary Outcome Measures

exclusive breastfeeding rate 24 hours before discharge
exclusive breastfeeding rate 24 hours before discharge

Secondary Outcome Measures

Time of Mother's Own Milk at starting feed(hours)
Time of Mother's Own Milk at starting feed(hours)
Proportion of first time Mother's Own Milk (%)
Proportion of first time Mother's Own Milk (%)
Duration of parenteral nutrition (days)
Duration of parenteral nutrition (days)
Time to total gastrointestinal feeding (days)
Time to total gastrointestinal feeding (days)
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

Full Information

First Posted
May 7, 2020
Last Updated
October 29, 2021
Sponsor
Nanjing Medical University
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT04383379
Brief Title
To Improve the Rate of Mother's Own Milk Feeding of Premature Infants in NICU
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality Improvement, Breast-feeding, Premature Infant
Keywords
Quality Improvement, breast-feeding, premature infant, cluster randomized controlled

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Continue current practices
Intervention Type
Behavioral
Intervention Name(s)
Experimental: Intervention group
Intervention Description
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.
Primary Outcome Measure Information:
Title
exclusive breastfeeding rate 24 hours before discharge
Description
exclusive breastfeeding rate 24 hours before discharge
Time Frame
two years
Secondary Outcome Measure Information:
Title
Time of Mother's Own Milk at starting feed(hours)
Description
Time of Mother's Own Milk at starting feed(hours)
Time Frame
two years
Title
Proportion of first time Mother's Own Milk (%)
Description
Proportion of first time Mother's Own Milk (%)
Time Frame
two years
Title
Duration of parenteral nutrition (days)
Description
Duration of parenteral nutrition (days)
Time Frame
two years
Title
Time to total gastrointestinal feeding (days)
Description
Time to total gastrointestinal feeding (days)
Time Frame
two years
Title
Pump milk times (times /d) and amount (ml / d) :1-3d, 4-7d ,8-14d
Description
Pump milk times (times /d) and amount (ml / d) :1-3d, 4-7d ,8-14d
Time Frame
two years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
120 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Han Shuping, PhD
Phone
+86-025-52226561
Email
shupinghan@njmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Zhangbin, PhD
Phone
+86-025-52226567
Email
zhangbinyu@njmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han Shuping, PhD
Organizational Affiliation
Nanjing Maternity and Child Health Care Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yu Zhangbin, PhD
Organizational Affiliation
Nanjing Maternity and Child Health Care Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Chen Xiaoqing, PhD
Organizational Affiliation
Jiangsu Maternity and Child Health Care Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deng Xiaoyi, PhD
Organizational Affiliation
Xuzhou Maternity and Child Health Care Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lu Hongyan, PhD
Organizational Affiliation
Affiliated Hospital of Jiangsu University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wu Xinping, PhD
Organizational Affiliation
Yangzhou Maternity and Child Health Care Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gao Yan, PhD
Organizational Affiliation
Lianyungang Maternity and Child Health Care Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Li Shuangshuang, PhD
Organizational Affiliation
Nantong Maternity and Child Health Care Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wan Jun, PhD
Organizational Affiliation
The First People's Hospital of Jiangyin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wu Mingfu, PhD
Organizational Affiliation
Yangzhou No.1 People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhu Lingling, PhD
Organizational Affiliation
Subei people's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhou Qin, PhD
Organizational Affiliation
Wuxi Maternity and Child Health Care Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wang Jun, PhD
Organizational Affiliation
The Affiliated Hospital of Xuzhou Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wang Huaiyan, PhD
Organizational Affiliation
Changzhou Maternal and Child Care Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing Maternity and Child Health Care Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han Shuping, PhD
Phone
+86-025-52226561
Email
shupinghan@njmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yu Zhangbin, PhD
Phone
+86-025-52226567
Email
zhangbinyu@njmu.edu.cn

12. IPD Sharing Statement

Citations:
PubMed Identifier
34819117
Citation
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.
Results Reference
derived

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To Improve the Rate of Mother's Own Milk Feeding of Premature Infants in NICU

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