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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Fudan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
China Medical Board

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-194

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