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

Premature Infant Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04383379
• Other study ID #: NMU-FY2016-73
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: October 2021
• Source: Nanjing Medical University
• Contact: Han Shuping, PhD
• Phone: +86-025-52226561
• Email: shupinghan[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 120 Days

Eligibility

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.

Related Conditions & MeSH terms

• Breast-feeding
• Premature Birth
• Premature Infant
• Quality Improvement

Intervention

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.

Locations

Country	Name	City	State
China	Nanjing Maternity and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (14)

Lead Sponsor

Collaborator

Nanjing Medical University

Affiliated Hospital of Jiangsu University, Changzhou Maternal and Child Care Hospital, Jiangsu Maternity and Child Health Care Hospital, Lianyungang Maternity and Child Health Care Hospital, Nanjing Maternity and Child Health Care Hospital, Nantong Maternity and Child Health Care Hospital, Subei people's Hospital, The Affiliated Hospital of Xuzhou Medical University, The First People's Hospital of Jiangyin, Wuxi Maternity and Child Health Care Hospital, Xuzhou Maternity and Child Health Care Hospital, Yangzhou Maternity and Child Health Care Hospital, Yangzhou No.1 People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	exclusive breastfeeding rate 24 hours before discharge	exclusive breastfeeding rate 24 hours before discharge	two years
Secondary	Time of Mother's Own Milk at starting feed(hours)	Time of Mother's Own Milk at starting feed(hours)	two years
Secondary	Proportion of first time Mother's Own Milk (%)	Proportion of first time Mother's Own Milk (%)	two years
Secondary	Duration of parenteral nutrition (days)	Duration of parenteral nutrition (days)	two years
Secondary	Time to total gastrointestinal feeding (days)	Time to total gastrointestinal feeding (days)	two years
Secondary	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