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CompletedNCT03453502Updated Nov 1, 2021

Improving Mother Milk Feeding Benefits in Neonatal Intensive Care Units

An interventional study of Quality improvement of breast milk feeding in Quality Improvement and Breast Milk, sponsored by Nanjing Medical University. Completed. Open to participants aged Up to 120 Days. Per ClinicalTrials.gov, last updated 2021-11-01.

Sponsored by Nanjing Medical University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
1,800
Allocation
Non-randomized
Ages
Up to 120 Days
Sex
All
01

Study 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.

Read the detailed description

Breast milk reduces the risk of serious prematurity related morbidities. Quality improvement is an effective means of increasing breast milk feeding.Twenty-seven hospitals in China will participate in the study, which aims to increase breastfeeding rate in the NICU and reduce the clinical complications in very low birth weight infants and extremely low birth weight infants. This study compared the clinical data of very low birth weight infants and extremely low birth weight infants in three phases:Before-intervention phase,Intervention phase and Sustainability phase. During the Intervention phase and Sustainability phase multiple intervention bundles of quality improvement were implemented.The investigators will compare breast milk feeding rate and neonatal outcomes in different phases.

02

Conditions studied

  • Quality Improvement
  • Breast Milk

Keywords

  • quality improvement
  • breast milk
03

Who can participate

Ages eligible
Up to 120 Days
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • premature Infants (Birth weight\<1500g)

Exclusion criteria

Exclusion Criteria:

  • mother with sever illness or communicable disease
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
1,800 participants (estimated)

Study arms

  • No intervention
    Before-intervention phase

    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.

  • Experimental
    Intervention phase

    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

  • Experimental
    Sustainability intervention phase

    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

  • BehavioralQuality improvement of breast milk feeding

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

05

What researchers measure

Primary outcomes

  1. mother own milk feeding rates

    Time frame: three years

Secondary outcomes

  1. NICU costs

    costs during hospitalization in NICU

    Time frame: three years

  2. the incidence of necrotizing enterocolitis (NEC)

    the incidence of necrotizing enterocolitis

    Time frame: three years

  3. the incidence of sepsis

    Time frame: three years

  4. Reduce the incidence of enteral feed intolerance

    Time frame: three years

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 33190629 ↗
08

Registry details

Key details

Study ID
NCT03453502
Lead sponsor
Nanjing Medical University
Collaborators
Nanjing Maternity and Child Health Care Hospital, Jiangsu Women and Children Health Hospital, The First People's Hospital of Lianyungang, Xuzhou Maternity and Child Health Care Hospital, The Second Hospital of Nanjing Medical University, Children's Hospital of Nanjing Medical University, Suqian Maternity and Child Health Care Hospital, Lianyungang Maternity and Child Health Care Hospital, Wuxi Women's & Children's Hospital, Suzhou Municipal Hospital, Yancheng Maternity and Child Health Care Hospital, The First People's Hospital of Yancheng, The Affiliated Jiangyin Hospital of Southeast University Medical College, The First People's Hospital of Zhangjiagang, The Affiliated Huaian NO.1 People's Hospital of Nanjing Medical University, Huaian Maternity and Child Health Care Hospital, Changzhou Maternal and Child Care Hospital, Zhenjiang Maternity and Child Health Care Hospital, The Affiliated Hospital of Xuzhou Medical University, Taizhou People's Hospital, Affiliated Hospital of Jiangsu University, First People's Hospital of Hangzhou, Wuxi Maternity and Child Health Care Hospital, Changzhou Children's Hospital, Northern Jiangsu People's Hospital, Children's Hospital of Soochow University, Nantong Maternity and Child Health Care Hospital
Responsible party
Zhangbin Yu (Principal Investigator, Nanjing Medical University) — Principal investigator
First posted
Mar 5, 2018
Start date
Jan 1, 2017
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Nov 1, 2021

Study contacts

Shuping Han, PhD
study director · Nanjing Maternity and Child Health Care Hospital
Zhangbin Yu, PhD
study director · Nanjing Maternity and Child Health Care Hospital
Jun Zhang, PhD
principal investigator · Nanjing Maternity and Child Health Care Hospital
Yuhua Hu, PhD
principal investigator · Jiangsu Women and Children Health Hospital
Shan Li, PhD
principal investigator · The First People's Hospital of Lianyungang
Xiaoyi Deng, PhD
principal investigator · Xuzhou Maternity and Child Health Care Hospital
Zelin Jiao, PhD
principal investigator · The Second Hospital of Nanjing Medical University
Rui Cheng, PhD
principal investigator · Children's Hospital of Nanjing Medical University
Weiyuan Wang, PhD
principal investigator · Suqian Maternity and Child Health Care Hospital
Yan Gao, PhD
principal investigator · Lianyungang Maternity and Child Health Care Hospital
Zhengying Li, PhD
principal investigator · Wuxi Women's & Children's Hospital
Sannan Wang, PhD
principal investigator · Suzhou Municipal Hospital
Jinlan Chai, PhD
principal investigator · Yancheng Maternity and Child Health Care Hospital
Zhun xu, PhD
principal investigator · The First People's Hospital of Yancheng
Jun Wan, PhD
principal investigator · The Affiliated Jiangyin Hospital of Southeast University Medical College
Weidong xu, PhD
principal investigator · The First People's Hospital of Zhangjiagang
Zhaofang Tian, PhD
principal investigator · The Affiliated Huaian NO.1 People's Hospital of Nanjing Medical University
Liangrong Han, PhD
principal investigator · Huaian Maternity and Child Health Care Hospital
Jinxiu Wang, PhD
principal investigator · Changzhou Maternal and Child Care Hospital
Xuqin Mao, PhD
principal investigator · Zhenjiang Maternity and Child Health Care Hospital
Jun Wang, PhD
principal investigator · The Affiliated Hospital of Xuzhou Medical University
Mei Xue, PhD
principal investigator · Taizhou People's Hospital
Hongyan Lu, PhD
principal investigator · Affiliated Hospital of Jiangsu University
Mingfu Wu, PhD
principal investigator · First People's Hospital of Hangzhou
Qin Zhou, PhD
principal investigator · Wuxi Maternity and Child Health Care Hospital
Wenjuan Tu, PhD
principal investigator · Changzhou Children's Hospital
Lingling Zhu, PhD
principal investigator · Northern Jiangsu People's Hospital
Bin Sun, PhD
principal investigator · Children's Hospital of Soochow University
Shuangshuang Li, PhD
principal investigator · Nantong Maternity and Child Health Care Hospital
Xiaohui Chen, PhD
principal investigator · Nanjing Maternity and Child Health Care Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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