Clinical trial NCT03453502: Improving Mother Milk Feeding Benefits in Neonatal Intensive Care Units
Official title: Improving Mother Milk Feeding Benefits in Neonatal Intensive Care Units Using the Evidence-based Practice for Quality Improvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality Improvement
Breast Milk
Keywords: quality improvement
breast milk
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Nanjing Maternity and Child Health Care Hospital
name: Jiangsu Women and Children Health Hospital
name: The First People's Hospital of Lianyungang
name: Xuzhou Maternity and Child Health Care Hospital
name: The Second Hospital of Nanjing Medical University
name: Children's Hospital of Nanjing Medical University
name: Suqian Maternity and Child Health Care Hospital
name: Lianyungang Maternity and Child Health Care Hospital
name: Wuxi Women's & Children's Hospital
name: Suzhou Municipal Hospital
name: Yancheng Maternity and Child Health Care Hospital
name: The First People's Hospital of Yancheng
name: The Affiliated Jiangyin Hospital of Southeast University Medical College
name: The First People's Hospital of Zhangjiagang
name: The Affiliated Huaian NO.1 People's Hospital of Nanjing Medical University
name: Huaian Maternity and Child Health Care Hospital
name: Changzhou Maternal and Child Care Hospital
name: Zhenjiang Maternity and Child Health Care Hospital
name: The Affiliated Hospital of Xuzhou Medical University
name: Taizhou People's Hospital
name: Affiliated Hospital of Jiangsu University
name: First People's Hospital of Hangzhou
name: Wuxi Maternity and Child Health Care Hospital
name: Changzhou Children's Hospital
name: Northern Jiangsu People's Hospital
name: Children's Hospital of Soochow University
name: Nantong Maternity and Child Health Care Hospital
First posted: 2018-03-05
Enrollment: 1800
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria:

* premature Infants (Birth weight\<1500g)

Exclusion Criteria:

* mother with sever illness or communicable disease

Primary outcomes:
measure: mother own milk feeding rates
timeFrame: three years
Secondary outcomes:
measure: NICU costs
timeFrame: three years
measure: the incidence of necrotizing enterocolitis (NEC)
timeFrame: three years
measure: the incidence of sepsis
timeFrame: three years
measure: Reduce the incidence of enteral feed intolerance
timeFrame: three years
Other outcomes:
Locations:
Study officials:
affiliation: Nanjing Maternity and Child Health Care Hospital
name: Shuping Han, PhD
role: STUDY_DIRECTOR
affiliation: Nanjing Maternity and Child Health Care Hospital
name: Zhangbin Yu, PhD
role: STUDY_DIRECTOR
affiliation: Nanjing Maternity and Child Health Care Hospital
name: Jun Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiangsu Women and Children Health Hospital
name: Yuhua Hu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First People's Hospital of Lianyungang
name: Shan Li, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xuzhou Maternity and Child Health Care Hospital
name: Xiaoyi Deng, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Hospital of Nanjing Medical University
name: Zelin Jiao, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Nanjing Medical University
name: Rui Cheng, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Suqian Maternity and Child Health Care Hospital
name: Weiyuan Wang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lianyungang Maternity and Child Health Care Hospital
name: Yan Gao, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuxi Women's & Children's Hospital
name: Zhengying Li, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Suzhou Municipal Hospital
name: Sannan Wang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yancheng Maternity and Child Health Care Hospital
name: Jinlan Chai, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First People's Hospital of Yancheng
name: Zhun xu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Jiangyin Hospital of Southeast University Medical College
name: Jun Wan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First People's Hospital of Zhangjiagang
name: Weidong xu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Huaian NO.1 People's Hospital of Nanjing Medical University
name: Zhaofang Tian, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Huaian Maternity and Child Health Care Hospital
name: Liangrong Han, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Changzhou Maternal and Child Care Hospital
name: Jinxiu Wang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhenjiang Maternity and Child Health Care Hospital
name: Xuqin Mao, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital of Xuzhou Medical University
name: Jun Wang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Taizhou People's Hospital
name: Mei Xue, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Jiangsu University
name: Hongyan Lu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: First People's Hospital of Hangzhou
name: Mingfu Wu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuxi Maternity and Child Health Care Hospital
name: Qin Zhou, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Changzhou Children's Hospital
name: Wenjuan Tu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northern Jiangsu People's Hospital
name: Lingling Zhu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Soochow University
name: Bin Sun, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantong Maternity and Child Health Care Hospital
name: Shuangshuang Li, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanjing Maternity and Child Health Care Hospital
name: Xiaohui Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.