Reduction of Infection in Neonatal Intensive Care Units Using the Evidence-based Practice for Improving Quality

August 5, 2018 updated by: Children's Hospital of Fudan University

Reduction of Infection in Neonatal Intensive Care Units Using the Evidence-based Practice for Improving Quality: A Cluster Randomised Trial

This 4-year cluster randomized controlled trial aims to determine whether implementation of Evidence-based Practice for Improving Quality (EPIQ) method can reduce hospital-acquired infection in Chinese Neonatal Intensive Care Units (NICUs).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Following randomization into two groups, the intervention NICUs (n = 12) will receive training in the EPIQ method and then develop, implement, and document evidence-based practice changes to reduce hospital-acquired infection. 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 NICUs (n = 12) will collect neonatal data and continue to provide standard care. Study subjects will be all preterm infants born at <34 weeks' gestation and admitted to participating NICUs during the trial (estimated n = 5,200 per year). Data analysis will be conducted to compare neonatal outcomes and health-care resources used between the intervention and control groups.

Study Type

Interventional

Enrollment (Anticipated)

15600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Shanghai First Maternity and Child Health Care Hospital
    • Anhui
      • Hefei, Anhui, China
        • The First Affiliated Hospital of Anhui Medical University
    • Beijing
      • Beijing, Beijing, China
        • Beijing Children's Hospital
    • Fujian
      • Fuzhou, Fujian, China
        • Fujian Maternity and Child Health Care Hospital
    • Gansu
      • Lanzhou, Gansu, China
        • Gansu Maternity and Child Health Care Hospital
    • Guangdong
      • Shenzhen, Guangdong, China
        • Shenzhen Maternity and Child Health Care Hospital
    • Guangxi
      • Nanning, Guangxi, China
        • Guangxi Maternity and Child Health Care Hospital
    • Guizhou
      • Guiyang, Guizhou, China
        • Guiyang Children's Hospital
    • Hebei
      • Shijiazhuang, Hebei, China
        • Children's Hospital of Hebei Province
    • Henan
      • Zhengzhou, Henan, China
        • Zhengzhou Children'S Hospital
    • Hubei
      • Wuhan, Hubei, China
        • Hubei Maternity and Child Health Care Hospital
      • Wuhan, Hubei, China
        • Tongji hospital affiliated to Tongji Medical College
    • Hunan
      • Changsha, Hunan, China
        • The Third Xiangya Hospital of Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Nanjing Children's Hospital
      • Nanjing, Jiangsu, China
        • Nanjing Maternity and Child Health Care Hospital
      • Suzhou, Jiangsu, China
        • Suzhou Municipal Hospital
      • Wuxi, Jiangsu, China
        • Wuxi Maternity and Child Health Care Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Jiangxi Children's Hospital
    • Shandong
      • Jinan, Shandong, China
        • Jinan Children's Hospital
      • Qingdao, Shandong, China
        • Qingdao Maternity and Child Health Care Hospital
    • Shanxi
      • Taiyuan, Shanxi, China
        • Shanxi Maternity and Child Health Care Hospital
      • Xian, Shanxi, China
        • Shanxi Maternity and Child Health Care Hospital
    • Xinjiang
      • Urumqi, Xinjiang, China
        • The first affiliated hospital of Xinjiang medical university
    • Zhejiang
      • Wenzhou, Zhejiang, China
        • The Second Affiliated Hospital of Wenzhou Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infants born at <34 weeks' gestation
  • Admitted to the participating NICUs within 7 days after birth
  • Admitted to the participating NICUs between May 1, 2015 and April 30, 2018

Exclusion Criteria:

  • Infants with major congenital anomalies
  • Infants who are moribund on admission (a decision is made to provide only palliative care)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EPIQ sites
Use Evidence-based Practice for Improving Quality (EPIQ) method to develop and implement evidence-based practice changes to reduce hospital-acquired infection
Behavioral: Evidence-based Practice for Improving Quality (EPIQ) method
The intervention NICUs (n = 12) will receive training in the Evidence-based Practice for Improving Quality (EPIQ) method and then develop, implement, and document evidence-based practice changes to reduce hospital-acquired infection. 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.
No Intervention: Control sites
Continue current practices

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of hospital-acquired infection
Time Frame: Three years
Combined cases of following types of hospital-acquired infection: ventilation associated pneumonia, central line-associated blood stream infection (CLABSI), blood stream infections excluding CLABSI, urinary tract infections, meningitis, clinical sepsis
Three years

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: Three years
Three years
Incidence of ventilation associated pneumonia
Time Frame: Three years
Three years
Incidence of central line-associated blood stream infection
Time Frame: Three years
Three years
Incidence of blood stream infection excluding CLABSI
Time Frame: Three years
Three years
Incidence of meningitis
Time Frame: Three years
Three years
Incidence of clinical sepsis
Time Frame: Three years
Three years
Incidence of urinary tract infections
Time Frame: Three years
Three years
Incidence of stage ≥2 necrotizing enterocolitis
Time Frame: Three years
Three years
Days on ventilation support
Time Frame: Three years
Three years
Days on total parenteral nutrition
Time Frame: Three years
Three years
Days on antibiotics
Time Frame: Three years
Three years
Days on inotropes
Time Frame: Three years
Three years
Infection-related mortality
Time Frame: Three years
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Collaborators

China Medical Board

Investigators

  • Principal Investigator: Yun Cao, MD, PHD, Children's Hospital of Fudan University
  • Principal Investigator: Vibhuti Shah, MD, Msc, University of Toronto
  • Principal Investigator: Shoo K Lee, MD, PHD, University of Toronto
  • Principal Investigator: Weiping Wang, MD, PHD, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 30, 2018

Study Registration Dates

First Submitted

November 5, 2015

First Submitted That Met QC Criteria

November 6, 2015

First Posted (Estimate)

November 9, 2015

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 5, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-194

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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