Improving Mother Milk Feeding Benefits in Neonatal Intensive Care Units

Not Applicable

Completed

• Conditions: Breast Milk; Quality Improvement
• Interventions: Behavioral: Quality improvement of breast milk feeding

• Registration Number: NCT03453502
• Lead Sponsor: Nanjing Medical University

Brief Summary

Twenty-seven hospitals in China will participate in the study, which aims to increase breastfeeding rate in the neonatal intensive care unit (NICU) and reduce the clinical complications in very low birth weight infants and extremely low birth weight infants.

Detailed Description

Breast milk reduces the risk of serious prematurity related morbidities. Quality improvement is an effective means of increasing breast milk feeding.Twenty-seven hospitals in China will participate in the study, which aims to increase breastfeeding rate in the NICU and reduce the clinical complications in very low birth weight infants and extremely low birth weight infants. This study compared the clinical data of very low birth weight infants and extremely low birth weight infants in three phases：Before-intervention phase，Intervention phase and Sustainability phase. During the Intervention phase and Sustainability phase multiple intervention bundles of quality improvement were implemented.The investigators will compare breast milk feeding rate and neonatal outcomes in different phases.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-05
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-29
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

• premature Infants (Birth weight<1500g)

Exclusion Criteria

• mother with sever illness or communicable disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention phase	Quality improvement of breast milk feeding	All the VLBW and ELBW infants who were admitted from January 2018 to December 2018 to the NICUs.During this phase,multiple intervention bundles of quality improvement will be implemented.
Sustainability intervention phase	Quality improvement of breast milk feeding	All the VLBW and ELBW infants who were admitted from January 2019 to December 2019to the NICUs.In the Sustainability intervention phase,multiple intervention bundles of quality improvement will be continuous implemented.

Primary Outcome Measures

Name	Time	Method
mother own milk feeding rates	three years

Secondary Outcome Measures

Name	Time	Method
the incidence of necrotizing enterocolitis (NEC)	three years	the incidence of necrotizing enterocolitis
Reduce the incidence of enteral feed intolerance	three years
NICU costs	three years	costs during hospitalization in NICU
the incidence of sepsis	three years