Clinical trial NCT02897388: A Quality Improvement Initiative to Increase Breast Milk Use in a Chinese NICU: a Pilot Study
Official title: A Quality Improvement Initiative to Increase Breast Milk Use in a Chinese Neonatal Intensive Care Unit (NICU): a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Extremely Premature
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 325
Sex: ALL
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: prevalence of breast milk feeding
timeFrame: up to 18 months
Secondary outcomes:
measure: Necrotizing enterocolitis(NEC) incidence
timeFrame: up to 18 months
measure: Nosocomial infection incidence
timeFrame: up to 18 months
measure: overall mortality rate
timeFrame: up to 18 months
measure: time to full feeding
timeFrame: up to 18 months
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Fudan University
name: Yi Yang, Ph.D
role: STUDY_CHAIR
References:
citation: Zhou Q, Zhang L, Lee SK, Chen C, Hu XJ, Liu C, Cao Y. A Quality Improvement Initiative to Increase Mother's Own Milk Use in a Chinese Neonatal Intensive Care Unit. Breastfeed Med. 2020 Apr;15(4):261-267. doi: 10.1089/bfm.2019.0290. Epub 2020 Mar 4.