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

NCT ID: NCT02897388

Last Updated: 2016-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 325 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-06-30

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.

Conditions

Infant, Extremely Premature

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Pre-intervention

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

intervention

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.

Group Type: EXPERIMENTAL

breast milk consume promotion

Intervention Type: OTHER

(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

Interventions

breast 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

Intervention Type: OTHER

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

• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi Yang, Ph.D

Role: STUDY_CHAIR

Children's Hospital of Fudan University

References

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.

Reference Type: DERIVED

PMID: 32129666 (View on PubMed)

Other Identifiers

CCCTG1

Identifier Type: -

Identifier Source: org_study_id