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

A Quality Improvement Initiative to Increase Breast Milk Use in a Chinese Neonatal Intensive Care Unit (NICU): a Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02897388
Enrollment
325
Registered
2016-09-13
Start date
2014-11-30
Completion date
2016-06-30
Last updated
2016-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Extremely Premature

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.

Interventions

OTHERbreast milk consume promotion

(1)Team building: organize a multidisciplinary breast milk consume improvement team;(2) Staff education: one nurse to train in Canada for 1 month as lactation coordinator, lactation consultant from Canada to teach NICU staff for 1 month; (3) Send breastmilk teaching materials for parents to teach mothers about breast milk feeding;(4) allocate an area in the NICU as a breast pumping room with breastfeeding pumps and chairs to support mothers pumping milk and feeding their babies; (5)purchase 10 breast pumps from Medela and establish a loaner program for mothers; (6)provide lactation counseling & promote consistent communication about the benefits of mothers' milk to encourage mothers to provide milk for their infants;(7)Coaching by lactation coordinator and nursing staff

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 37 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
prevalence of breast milk feedingup to 18 monthsto compare the breast milk feeding incidence between pre-intervention and intervention period

Secondary

MeasureTime frameDescription
Necrotizing enterocolitis(NEC) incidenceup to 18 monthsto compare the NEC incidence between pre-intervention and intervention period
Nosocomial infection incidenceup to 18 monthsto compare the nosocomial infection incidence between pre-intervention and intervention period
overall mortality rateup to 18 monthsto compare the overall mortality rate between pre-intervention and intervention period
time to full feedingup to 18 monthsto compare the time to full feeding between pre-intervention and intervention period

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026