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

Sponsor

Children's Hospital of Fudan University (Other)

Overall Status

Completed

CT.gov ID

NCT02897388

Collaborator

(none)

325

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infant, Extremely Premature	Other: breast milk consume promotion	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

325 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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
Experimental: 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.	Other: 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

Arm

Intervention/Treatment

No Intervention: 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

Experimental: 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.

Other: 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

Outcome Measures

Primary Outcome Measures

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

Necrotizing enterocolitis(NEC) incidence [up to 18 months]
to compare the NEC incidence between pre-intervention and intervention period
Nosocomial infection incidence [up to 18 months]
to compare the nosocomial infection 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 37 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Presence of breast milk feeding contraindications
Severe illness with contraindications for feeding

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Children's Hospital of Fudan University

Investigators

Study Chair: Yi Yang, Ph.D, Children's Hospital of Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Children's Hospital of Fudan University

ClinicalTrials.gov Identifier:

NCT02897388

Other Study ID Numbers:

CCCTG1

First Posted:

Sep 13, 2016

Last Update Posted:

Sep 13, 2016

Last Verified:

Sep 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of Sep 13, 2016