NCT03453502

Brief Summary

Twenty-seven hospitals in China will participate in the study, which aims to increase breastfeeding rate in the neonatal intensive care unit (NICU) and reduce the clinical complications in very low birth weight infants and extremely low birth weight infants.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
completed

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

Study Start

First participant enrolled

January 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

3 years

First QC Date

February 27, 2018

Last Update Submit

October 29, 2021

Conditions

Keywords

quality improvementbreast milk

Outcome Measures

Primary Outcomes (1)

  • mother own milk feeding rates

    three years

Secondary Outcomes (4)

  • NICU costs

    three years

  • the incidence of necrotizing enterocolitis (NEC)

    three years

  • the incidence of sepsis

    three years

  • Reduce the incidence of enteral feed intolerance

    three years

Study Arms (3)

Before-intervention phase

NO INTERVENTION

All the very low birth weight (VLBW) and extremely low birth weight (ELBW) infants who were admitted from January 2017 to December 2017 to the NICUs of different hospitals.

Intervention phase

EXPERIMENTAL

All the VLBW and ELBW infants who were admitted from January 2018 to December 2018 to the NICUs.During this phase,multiple intervention bundles of quality improvement will be implemented.

Behavioral: Quality improvement of breast milk feeding

Sustainability intervention phase

EXPERIMENTAL

All the VLBW and ELBW infants who were admitted from January 2019 to December 2019to the NICUs.In the Sustainability intervention phase,multiple intervention bundles of quality improvement will be continuous implemented.

Behavioral: Quality improvement of breast milk feeding

Interventions

During the Intervention phase and Sustainability phase ,The NICUs will receive training of multiple evidence based quality improvement methods.

Intervention phaseSustainability intervention phase

Eligibility Criteria

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

You may qualify if:

  • premature Infants (Birth weight\<1500g)

You may not qualify if:

  • mother with sever illness or communicable disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Xu Y, Yu Z, Li Q, Zhou J, Yin X, Ma Y, Yin Y, Jiang S, Zhu R, Wu Y, Han L, Gao Y, Xue M, Qiao Y, Zhu L, Tu W, Wu M, Wan J, Wang W, Deng X, Li S, Wang S, Chen X, Zhou Q, Wang J, Cheng R, Wang J, Han S. Dose-dependent effect of human milk on Bronchopulmonary dysplasia in very low birth weight infants. BMC Pediatr. 2020 Nov 16;20(1):522. doi: 10.1186/s12887-020-02394-1.

Study Officials

  • Shuping Han, PhD

    Nanjing Maternity and Child Health Care Hospital

    STUDY DIRECTOR
  • Zhangbin Yu, PhD

    Nanjing Maternity and Child Health Care Hospital

    STUDY DIRECTOR
  • Jun Zhang, PhD

    Nanjing Maternity and Child Health Care Hospital

    PRINCIPAL INVESTIGATOR
  • Yuhua Hu, PhD

    Jiangsu Women and Children Health Hospital

    PRINCIPAL INVESTIGATOR
  • Shan Li, PhD

    The First People's Hospital of Lianyungang

    PRINCIPAL INVESTIGATOR
  • Xiaoyi Deng, PhD

    Xuzhou Maternity and Child Health Care Hospital

    PRINCIPAL INVESTIGATOR
  • Zelin Jiao, PhD

    The Second Hospital of Nanjing Medical University

    PRINCIPAL INVESTIGATOR
  • Rui Cheng, PhD

    Children's Hospital of Nanjing Medical University

    PRINCIPAL INVESTIGATOR
  • Weiyuan Wang, PhD

    Suqian Maternity and Child Health Care Hospital

    PRINCIPAL INVESTIGATOR
  • Yan Gao, PhD

    Lianyungang Maternity and Child Health Care Hospital

    PRINCIPAL INVESTIGATOR
  • Zhengying Li, PhD

    Wuxi Women's & Children's Hospital

    PRINCIPAL INVESTIGATOR
  • Sannan Wang, PhD

    Suzhou Municipal Hospital

    PRINCIPAL INVESTIGATOR
  • Jinlan Chai, PhD

    Yancheng Maternity and Child Health Care Hospital

    PRINCIPAL INVESTIGATOR
  • Zhun xu, PhD

    The First People's Hospital of Yancheng

    PRINCIPAL INVESTIGATOR
  • Jun Wan, PhD

    The Affiliated Jiangyin Hospital of Southeast University Medical College

    PRINCIPAL INVESTIGATOR
  • Weidong xu, PhD

    The First People's Hospital of Zhangjiagang

    PRINCIPAL INVESTIGATOR
  • Zhaofang Tian, PhD

    The Affiliated Huaian NO.1 People's Hospital of Nanjing Medical University

    PRINCIPAL INVESTIGATOR
  • Liangrong Han, PhD

    Huaian Maternity and Child Health Care Hospital

    PRINCIPAL INVESTIGATOR
  • Jinxiu Wang, PhD

    Changzhou Maternal and Child Care Hospital

    PRINCIPAL INVESTIGATOR
  • Xuqin Mao, PhD

    Zhenjiang Maternity and Child Health Care Hospital

    PRINCIPAL INVESTIGATOR
  • Jun Wang, PhD

    The Affiliated Hospital of Xuzhou Medical University

    PRINCIPAL INVESTIGATOR
  • Mei Xue, PhD

    Taizhou People's Hospital

    PRINCIPAL INVESTIGATOR
  • Hongyan Lu, PhD

    Affiliated Hospital of Jiangsu University

    PRINCIPAL INVESTIGATOR
  • Mingfu Wu, PhD

    First People's Hospital of Hangzhou

    PRINCIPAL INVESTIGATOR
  • Qin Zhou, PhD

    Wuxi Maternity and Child Health Care Hospital

    PRINCIPAL INVESTIGATOR
  • Wenjuan Tu, PhD

    Changzhou Children's Hospital

    PRINCIPAL INVESTIGATOR
  • Lingling Zhu, PhD

    Northern Jiangsu People's Hospital

    PRINCIPAL INVESTIGATOR
  • Bin Sun, PhD

    Children's Hospital of Soochow University

    PRINCIPAL INVESTIGATOR
  • Shuangshuang Li, PhD

    Nantong Maternity and Child Health Care Hospital

    PRINCIPAL INVESTIGATOR
  • Xiaohui Chen, PhD

    Nanjing Maternity and Child Health Care Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 5, 2018

Study Start

January 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

November 1, 2021

Record last verified: 2021-10