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

Not Applicable

• Conditions: Breast-feeding; Premature Infant; Quality Improvement

• Registration Number: NCT04383379
• Lead Sponsor: Nanjing Medical University

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.

Study Timeline

• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-12
• Study Start: 2020-05-15
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-29
• Last Update Posted: 2021-11-01
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
exclusive breastfeeding rate 24 hours before discharge	two years	exclusive breastfeeding rate 24 hours before discharge

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nanjing Maternity and Child Health Care Hospital; 🇨🇳 Nanjing, Jiangsu, China