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

Fudan University

Status: Completed

Conditions: Infant, Extremely Premature

Treatments: Other: breast milk consume promotion

Study type: Interventional

Funder types: Other

Identifiers

NCT02897388

CCCTG1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 325 patients

Sex: All

Ages: Under 37 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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325 participants in 2 patient groups

Pre-intervention

No Intervention group

Description:

all very low birth weight infants admitted to the NICU at Fudan University Children's Hospital from January 2015 through March 2015 (which is the period before any intervention started)who meet the enroll criteria

intervention

Experimental group

Description:

all very low birth weight infants admitted to the NICU at Fudan University Children's Hospital from April 2015 through June 2016 who meet the enroll criteria. A series of breast milk consume promotion interventions would implemented during this intervention period, which including build local lactation team, set breast milk feeding room, train NICU staff etc.

Treatment:

Other: breast milk consume promotion