NCT04383379

Brief Summary

Thirteen hospitals in China will participate in the study, which objectives of this study is to improve the rate of mother's own milk feeding of premature infants in neonatal intensive care unit(NICU), evaluate the effectiveness of improving the quality of breastfeeding in clinical use ,form standardized process and improve clinical medical quality of premature infants.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

May 15, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

2 years

First QC Date

May 7, 2020

Last Update Submit

October 29, 2021

Conditions

Quality ImprovementBreast-feedingPremature Infant

Keywords

Quality Improvementbreast-feedingpremature infantcluster randomized controlled

Outcome Measures

Primary Outcomes (1)

  • exclusive breastfeeding rate 24 hours before discharge

    exclusive breastfeeding rate 24 hours before discharge

    two years

Secondary Outcomes (5)

  • Time of Mother's Own Milk at starting feed（hours）

    two years

  • Proportion of first time Mother's Own Milk (%)

    two years

  • Duration of parenteral nutrition (days)

    two years

  • Time to total gastrointestinal feeding (days)

    two years

  • Pump milk times (times /d) and amount (ml / d) ：1-3d, 4-7d ,8-14d

    two years

Study Arms (2)

Intervention group

EXPERIMENTAL

6 NICUs in the intervention group . The participating units of the intervention group determine the improvement items (one or more) in each quarter from the list of best practices of breast feeding quality improvement of Jiangsu Province, and report the improvement plan to the supervision unit, and recommend the application of PDSA (plan-do-study-act) for the implementation of quality improvement loop. Report the implementation of quality improvement to the supervision unit on a quarterly basis.

Behavioral: Experimental: Intervention group

control group

NO INTERVENTION

Continue current practices

Interventions

Experimental: Intervention groupBEHAVIORAL

The intervention NICUs (n = 6) will receive training in the Evidence-based Practice for Improving Quality (EPIQ) method and then develop, implement, and document evidence-based practice changes toimprove the rate of breastfeeding . Compliance with practice changes and neonatal outcomes will be monitored. NICUs will receive quarterly feedback on their progress, as well as access to implementation support.

Intervention group

Eligibility Criteria

AgeUp to 120 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Weight less than 1500g or gestational age less than 32 weeks;
  • Admission to NICU.

You may not qualify if:

  • Pregnancy with serious diseases, infectious diseases or other medical contraindications for breast-feeding (such as galactosemia);
  • infants did not survive were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

RECRUITING

Related Publications (1)

  • Huo J, Wu X, Gu C, Yu Z, Zhang J, Chen X, Zhu J, Liu F, Liu B, Li Q, Han S. Using a WeChat mini-program-based lactation consultant intervention to increase the consumption of mother's own milk by preterm infants in the neonatal intensive care unit: a study protocol for a cluster randomized controlled trial. Trials. 2021 Nov 24;22(1):834. doi: 10.1186/s13063-021-05731-6.

    PMID: 34819117DERIVED

MeSH Terms

Conditions

Breast FeedingPremature Birth

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Han Shuping, PhD

    Nanjing Maternity and Child Health Care Hospital

    STUDY DIRECTOR

  • Yu Zhangbin, PhD

    Nanjing Maternity and Child Health Care Hospital

    STUDY DIRECTOR

  • Chen Xiaoqing, PhD

    Jiangsu Maternity and Child Health Care Hospital

    PRINCIPAL INVESTIGATOR

  • Deng Xiaoyi, PhD

    Xuzhou Maternity and Child Health Care Hospital

    PRINCIPAL INVESTIGATOR

  • Lu Hongyan, PhD

    Affiliated Hospital of Jiangsu University

    PRINCIPAL INVESTIGATOR

  • Wu Xinping, PhD

    Yangzhou Maternity and Child Health Care Hospital

    PRINCIPAL INVESTIGATOR

  • Gao Yan, PhD

    Lianyungang Maternity and Child Health Care Hospital

    PRINCIPAL INVESTIGATOR

  • Li Shuangshuang, PhD

    Nantong Maternity and Child Health Care Hospital

    PRINCIPAL INVESTIGATOR

  • Wan Jun, PhD

    The First People's Hospital of Jiangyin

    PRINCIPAL INVESTIGATOR

  • Wu Mingfu, PhD

    Yangzhou No.1 People's Hospital

    PRINCIPAL INVESTIGATOR

  • Zhu Lingling, PhD

    Subei people's Hospital

    PRINCIPAL INVESTIGATOR

  • Zhou Qin, PhD

    Wuxi Maternity and Child Health Care Hospital

    PRINCIPAL INVESTIGATOR

  • Wang Jun, PhD

    The Affiliated Hospital of Xuzhou Medical University

    PRINCIPAL INVESTIGATOR

  • Wang Huaiyan, PhD

    Changzhou Maternal and Child Care Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Han Shuping, PhD

CONTACT

+86-025-52226561shupinghan@njmu.edu.cn

Yu Zhangbin, PhD

CONTACT

+86-025-52226567zhangbinyu@njmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator of Nan Jing Maternity and Child Health Care Hospital

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 12, 2020

Study Start

May 15, 2020

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

CN(1)