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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04383379
Enrollment
1500
Registered
2020-05-12
Start date
2020-05-15
Completion date
2022-04-30
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast-feeding, Premature Infant, Quality Improvement

Keywords

Quality Improvement, breast-feeding, premature infant, cluster randomized controlled

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.

Interventions

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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 120 Days
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
exclusive breastfeeding rate 24 hours before dischargetwo yearsexclusive breastfeeding rate 24 hours before discharge

Secondary

MeasureTime frameDescription
Time of Mother's Own Milk at starting feed(hours)two yearsTime of Mother's Own Milk at starting feed(hours)
Proportion of first time Mother's Own Milk (%)two yearsProportion of first time Mother's Own Milk (%)
Duration of parenteral nutrition (days)two yearsDuration of parenteral nutrition (days)
Time to total gastrointestinal feeding (days)two yearsTime to total gastrointestinal feeding (days)
Pump milk times (times /d) and amount (ml / d) :1-3d, 4-7d ,8-14dtwo yearsPump milk times (times /d) and amount (ml / d) :1-3d, 4-7d ,8-14d

Countries

China

Contacts

Primary ContactHan Shuping, PhD
shupinghan@njmu.edu.cn+86-025-52226561
Backup ContactYu Zhangbin, PhD
zhangbinyu@njmu.edu.cn+86-025-52226567

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026