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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Quality Improvement, Breast-feeding, Premature Infant

Intervention / Treatment
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* Behavioral: Experimental: Intervention group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 120 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* 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.<br>|
| No Intervention: control group<br>Continue current practices | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast-feeding, Quality Improvement, premature infant, cluster randomized controlled