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

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: Quality Improvement; Premature Infant; Breast-feeding
• Intervention / Treatment: Behavioral: Experimental: Intervention group

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

• Study Contact: Name: Yu Zhangbin, PhD; Phone Number: +86-025-52226567; Email: zhangbinyu@njmu.edu.cn

Study Locations

• China
  • 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

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

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
exclusive breastfeeding rate 24 hours before discharge	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 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 (%)	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

Collaborators and Investigators

• 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
• 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

General Publications

• 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.

Study record dates

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

• Keywords: premature infant; Quality Improvement; breast-feeding; cluster randomized controlled
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• 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