Improving Mother Milk Feeding Benefits in Neonatal Intensive Care Units

NCT ID: NCT03453502

Last Updated: 2021-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Quality Improvement Breast Milk

Keywords

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quality improvement breast milk

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Quality improvement of breast milk feeding

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Quality improvement of breast milk feeding

Intervention Type BEHAVIORAL

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

Interventions

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Quality improvement of breast milk feeding

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* premature Infants (Birth weight\<1500g)

Exclusion Criteria

* mother with sever illness or communicable disease
Maximum Eligible Age

120 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Maternity and Child Health Care Hospital

OTHER

Sponsor Role collaborator

Jiangsu Women and Children Health Hospital

UNKNOWN

Sponsor Role collaborator

The First People's Hospital of Lianyungang

OTHER

Sponsor Role collaborator

Xuzhou Maternity and Child Health Care Hospital

OTHER

Sponsor Role collaborator

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role collaborator

Children's Hospital of Nanjing Medical University

OTHER

Sponsor Role collaborator

Suqian Maternity and Child Health Care Hospital

UNKNOWN

Sponsor Role collaborator

Lianyungang Maternity and Child Health Care Hospital

UNKNOWN

Sponsor Role collaborator

Wuxi Women's & Children's Hospital

OTHER

Sponsor Role collaborator

Suzhou Municipal Hospital

OTHER

Sponsor Role collaborator

Yancheng Maternity and Child Health Care Hospital

UNKNOWN

Sponsor Role collaborator

The First People's Hospital of Yancheng

UNKNOWN

Sponsor Role collaborator

The Affiliated Jiangyin Hospital of Southeast University Medical College

UNKNOWN

Sponsor Role collaborator

The First People's Hospital of Zhangjiagang

UNKNOWN

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

Huaian Maternity and Child Health Care Hospital

UNKNOWN

Sponsor Role collaborator

Changzhou Maternal and Child Care Hospital

OTHER

Sponsor Role collaborator

Zhenjiang Maternity and Child Health Care Hospital

UNKNOWN

Sponsor Role collaborator

The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role collaborator

Taizhou People's Hospital

UNKNOWN

Sponsor Role collaborator

Affiliated Hospital of Jiangsu University

OTHER

Sponsor Role collaborator

First People's Hospital of Hangzhou

OTHER

Sponsor Role collaborator

Wuxi Maternity and Child Health Care Hospital

UNKNOWN

Sponsor Role collaborator

Changzhou Children's Hospital

UNKNOWN

Sponsor Role collaborator

Northern Jiangsu People's Hospital

OTHER

Sponsor Role collaborator

Children's Hospital of Soochow University

OTHER

Sponsor Role collaborator

Nantong Maternity and Child Health Care Hospital

UNKNOWN

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Zhangbin Yu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shuping Han, PhD

Role: STUDY_DIRECTOR

Nanjing Maternity and Child Health Care Hospital

Zhangbin Yu, PhD

Role: STUDY_DIRECTOR

Nanjing Maternity and Child Health Care Hospital

Jun Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Nanjing Maternity and Child Health Care Hospital

Yuhua Hu, PhD

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Women and Children Health Hospital

Shan Li, PhD

Role: PRINCIPAL_INVESTIGATOR

The First People's Hospital of Lianyungang

Xiaoyi Deng, PhD

Role: PRINCIPAL_INVESTIGATOR

Xuzhou Maternity and Child Health Care Hospital

Zelin Jiao, PhD

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Nanjing Medical University

Rui Cheng, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Nanjing Medical University

Weiyuan Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

Suqian Maternity and Child Health Care Hospital

Yan Gao, PhD

Role: PRINCIPAL_INVESTIGATOR

Lianyungang Maternity and Child Health Care Hospital

Zhengying Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Wuxi Women's & Children's Hospital

Sannan Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

Suzhou Municipal Hospital

Jinlan Chai, PhD

Role: PRINCIPAL_INVESTIGATOR

Yancheng Maternity and Child Health Care Hospital

Zhun xu, PhD

Role: PRINCIPAL_INVESTIGATOR

The First People's Hospital of Yancheng

Jun Wan, PhD

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Jiangyin Hospital of Southeast University Medical College

Weidong xu, PhD

Role: PRINCIPAL_INVESTIGATOR

The First People's Hospital of Zhangjiagang

Zhaofang Tian, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Liangrong Han, PhD

Role: PRINCIPAL_INVESTIGATOR

Huaian Maternity and Child Health Care Hospital

Jinxiu Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

Changzhou Maternal and Child Care Hospital

Xuqin Mao, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhenjiang Maternity and Child Health Care Hospital

Jun Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Xuzhou Medical University

Mei Xue, PhD

Role: PRINCIPAL_INVESTIGATOR

Taizhou People's Hospital

Hongyan Lu, PhD

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Jiangsu University

Mingfu Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

First People's Hospital of Hangzhou

Qin Zhou, PhD

Role: PRINCIPAL_INVESTIGATOR

Wuxi Maternity and Child Health Care Hospital

Wenjuan Tu, PhD

Role: PRINCIPAL_INVESTIGATOR

Changzhou Children's Hospital

Lingling Zhu, PhD

Role: PRINCIPAL_INVESTIGATOR

Northern Jiangsu People's Hospital

Bin Sun, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Soochow University

Shuangshuang Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Nantong Maternity and Child Health Care Hospital

Xiaohui Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Nanjing Maternity and Child Health Care Hospital

References

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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.

Reference Type DERIVED
PMID: 33190629 (View on PubMed)

Other Identifiers

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NMU-FY2017-350

Identifier Type: -

Identifier Source: org_study_id