A Quality Improvement Initiative to Increase Breast Milk Use in a Chinese NICU: a Pilot Study

Not Applicable

Completed

• Conditions: Infant, Extremely Premature

• Registration Number: NCT02897388
• Lead Sponsor: Children's Hospital of Fudan University

Brief Summary

To assess the prevalence of breast milk feeding in a NICU in China, to implement a quality improvement program to increase breast milk feeding, and to evaluate its impact.

Detailed Description

The benefits of breast milk are well recognized for providing health benefits in early infancy and extending into adulthood, and breast milk feeding is promoted by numerous professional organizations. However, for various reasons, in neonatal intensive care unit in China, most infants are separated from their parents and are fed infant formula exclusively. To address this problem, the investigators propose to carry out a pilot study to assess the prevalence of breast milk feeding in a NICU of a tertiary teaching hospital in China, and then to introduce an intervention program to increase the prevalence of breast milk feeding and to evaluate the impact of this program.

The intervention would include building a nutrition team in the NICU, training of a lactation coordinator and nursing staff by a team from Mount Sinai Hospital, providing parents with education on breast milk feeding, providing access to breast pumps through a lend/lease program and providing a breast pumping room for parents. The investigators will collect data on breast milk feeding, including prevalence and reasons for not breast milk feeding during both the pre-intervention and intervention period. The investigators will also assess the enrolled infants' weight gain from admission to discharge, incidence of nosocomial infection and mortality, and average length of stay in the NICU, to assess the efficacy of the breast milk feeding intervention.

This trial has the potential to dramatically change feeding of infants in Chinese NICUs from exclusive infant formula to breast milk, with potential impacts on nosocomial infection, growth, development and hospital length of stay.

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-08-31
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-07
• Last Update Submitted: 2016-09-07
• Study First Posted: 2016-09-13
• Last Update Posted: 2016-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 325

Inclusion Criteria

1. all very low birth weight(birthweight ≤ 1500g)infants admitted to the NICU of Children's Hospital of Fudan University
2. informed consent is given

Exclusion Criteria

1. Presence of breast milk feeding contraindications
2. Severe illness with contraindications for feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
prevalence of breast milk feeding	up to 18 months	to compare the breast milk feeding incidence between pre-intervention and intervention period

Secondary Outcome Measures

Name	Time	Method
Nosocomial infection incidence	up to 18 months	to compare the nosocomial infection incidence between pre-intervention and intervention period
Necrotizing enterocolitis(NEC) incidence	up to 18 months	to compare the NEC incidence between pre-intervention and intervention period
overall mortality rate	up to 18 months	to compare the overall mortality rate between pre-intervention and intervention period
time to full feeding	up to 18 months	to compare the time to full feeding between pre-intervention and intervention period