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

Nanjing Medical University

Status: Unknown

Conditions: Quality Improvement; Premature Infant; Breast-feeding

Treatments: Behavioral: Experimental: Intervention group

Study type: Interventional

Funder types: Other

Identifiers

NCT04383379

NMU-FY2016-73

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: Under 120 days old

Volunteers: No 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

Intervention group

Experimental group

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.

Treatment:

Behavioral: Experimental: Intervention group

control group

No Intervention group

Description:

Continue current practices