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

NCT02897388 | Completed DMC

• 1 other identifier: CCCTG1
• Study Type: interventional
• Target: 325
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infant, Extremely Premature

Outcome Measures

Primary Outcomes (1)

• prevalence of breast milk feeding

  to compare the breast milk feeding incidence between pre-intervention and intervention period

  up to 18 months

Secondary Outcomes (4)

• Necrotizing enterocolitis(NEC) incidence

  up to 18 months

• Nosocomial infection incidence

  up to 18 months

• overall mortality rate

  up to 18 months

• time to full feeding

  up to 18 months

Study Arms (2)

Pre-intervention

NO 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

intervention

EXPERIMENTAL

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

Interventions

breast milk consume promotion 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

intervention

Eligibility Criteria

• Age: Up to 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Related Publications (1)

• 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.

  PMID: 32129666 DERIVED

Study Officials

• Yi Yang, Ph.D

  Children's Hospital of Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 13, 2016
• Study Start: November 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 13, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share