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To Improve the Rate of Mother's Own Milk Feeding of Premature Infants in NICU

NCT ID: NCT04383379

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-15

Study Completion Date

2022-04-30

Brief Summary

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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.

Detailed Description

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In this study, the cluster randomized controlled matching design was used. Considering that evidence-based practice for improving quality(EPIQ) method is not only to improve the quality of individual, but also to improve the quality of breast-feeding of the whole neonatal intensive care unit(NICU), so a hospital was chosen as a cluster. The supervision unit is used for the quality control , coordination and technical support in the whole study process.The two NICU with similar number of premature infants, the same scale of NICU and little difference in the recognition of breast-feeding quality improvement measures that meet the inclusion criteria are taken as the a floor, and then randomly divided into two groups, taking the NICU as intervention group or the control group can avoid the individual influence of the intervention. In this study, recruited 12 NICUs. The purpose of study is to to increase the consumption of mother's own milk of premature infants through the existing measures of improving the breastfeeding quality, and then to improve the quality of life of the premature infant, and to further evaluate whether this model of improving the breastfeeding quality can be promoted in other NICU.

Conditions

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Quality Improvement Breast-feeding Premature Infant

Keywords

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Quality Improvement breast-feeding premature infant cluster randomized controlled

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention group

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.

Group Type EXPERIMENTAL

Experimental: Intervention group

Intervention Type BEHAVIORAL

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.

control group

Continue current practices

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Experimental: Intervention group

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 Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnancy with serious diseases, infectious diseases or other medical contraindications for breast-feeding (such as galactosemia);
* infants did not survive were excluded.
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 Maternity and Child Health Care Hospital

UNKNOWN

Sponsor Role collaborator

Xuzhou Maternity and Child Health Care Hospital

OTHER

Sponsor Role collaborator

Affiliated Hospital of Jiangsu University

OTHER

Sponsor Role collaborator

Yangzhou Maternity and Child Health Care Hospital

UNKNOWN

Sponsor Role collaborator

Lianyungang Maternity and Child Health Care Hospital

UNKNOWN

Sponsor Role collaborator

Nantong Maternity and Child Health Care Hospital

UNKNOWN

Sponsor Role collaborator

The First People's Hospital of Jiangyin

UNKNOWN

Sponsor Role collaborator

Yangzhou No.1 People's Hospital

OTHER

Sponsor Role collaborator

Subei people's Hospital

UNKNOWN

Sponsor Role collaborator

Wuxi Maternity and Child Health Care Hospital

UNKNOWN

Sponsor Role collaborator

The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role collaborator

Changzhou Maternal and Child Care Hospital

OTHER

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Zhangbin Yu

Principal Investigator of Nan Jing Maternity and Child Health Care Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Han Shuping, PhD

Role: STUDY_DIRECTOR

Nanjing Maternity and Child Health Care Hospital

Yu Zhangbin, PhD

Role: STUDY_DIRECTOR

Nanjing Maternity and Child Health Care Hospital

Chen Xiaoqing, PhD

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Maternity and Child Health Care Hospital

Deng Xiaoyi, PhD

Role: PRINCIPAL_INVESTIGATOR

Xuzhou Maternity and Child Health Care Hospital

Lu Hongyan, PhD

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Jiangsu University

Wu Xinping, PhD

Role: PRINCIPAL_INVESTIGATOR

Yangzhou Maternity and Child Health Care Hospital

Gao Yan, PhD

Role: PRINCIPAL_INVESTIGATOR

Lianyungang Maternity and Child Health Care Hospital

Li Shuangshuang, PhD

Role: PRINCIPAL_INVESTIGATOR

Nantong Maternity and Child Health Care Hospital

Wan Jun, PhD

Role: PRINCIPAL_INVESTIGATOR

The First People's Hospital of Jiangyin

Wu Mingfu, PhD

Role: PRINCIPAL_INVESTIGATOR

Yangzhou No.1 People's Hospital

Zhu Lingling, PhD

Role: PRINCIPAL_INVESTIGATOR

Subei people's Hospital

Zhou Qin, PhD

Role: PRINCIPAL_INVESTIGATOR

Wuxi Maternity and Child Health Care Hospital

Wang Jun, PhD

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Xuzhou Medical University

Wang Huaiyan, PhD

Role: PRINCIPAL_INVESTIGATOR

Changzhou Maternal and Child Care Hospital

Locations

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Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Han Shuping, PhD

Role: CONTACT

Phone: +86-025-52226561

Email: [email protected]

Yu Zhangbin, PhD

Role: CONTACT

Phone: +86-025-52226567

Email: [email protected]

Facility Contacts

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Han Shuping, PhD

Role: primary

Yu Zhangbin, PhD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 34819117 (View on PubMed)

Other Identifiers

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NMU-FY2016-73

Identifier Type: -

Identifier Source: org_study_id