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

Primary Purpose

Nosocomial Infections

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Evidence-based Practice for Improving Quality (EPIQ) method
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Nosocomial Infections focused on measuring Intensive Care, Neonatal, Nosocomial Infections, Quality Improvement

Eligibility Criteria

undefined - 120 Days (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The First Affiliated Hospital of Anhui Medical University
  • Beijing Children's Hospital
  • Fujian Maternity and Child Health Care Hospital
  • Gansu Maternity and Child Health Care Hospital
  • Shenzhen Maternity and Child Health Care Hospital
  • Guangxi Maternity and Child Health Care Hospital
  • Guiyang Children's Hospital
  • Children's Hospital of Hebei Province
  • Zhengzhou Children's Hospital
  • Hubei Maternity and Child Health Care Hospital
  • Tongji Hospital Affiliated to Tongji Medical College
  • The Third Xiangya Hospital of Central South University
  • Nanjing Children's Hospital
  • Nanjing Maternity and Child Health Care Hospital
  • Suzhou Municipal Hospital
  • Wuxi Maternity and Child Health Care Hospital
  • Jiangxi Children's Hospital
  • Jinan Children's Hospital
  • Qingdao Maternity and Child Health Care Hospital
  • Shanxi Maternity and Child Health Care Hospital
  • Shanxi Maternity and Child Health Care Hospital
  • The First Affiliated Hospital of Xinjiang Medical University
  • The Second Affiliated Hospital of Wenzhou Medical College
  • Shanghai First Maternity and Child Health Care Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EPIQ sites

Control sites

Arm Description

Use Evidence-based Practice for Improving Quality (EPIQ) method to develop and implement evidence-based practice changes to reduce hospital-acquired infection

Continue current practices

Outcomes

Primary Outcome Measures

Incidence of hospital-acquired infection
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

Secondary Outcome Measures

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

Full Information

First Posted
November 5, 2015
Last Updated
August 5, 2018
Sponsor
Children's Hospital of Fudan University
Collaborators
China Medical Board
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1. Study Identification

Unique Protocol Identification Number
NCT02600195
Brief Title
Reduction of Infection in Neonatal Intensive Care Units Using the Evidence-based Practice for Improving Quality
Official Title
Reduction of Infection in Neonatal Intensive Care Units Using the Evidence-based Practice for Improving Quality: A Cluster Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University
Collaborators
China Medical Board

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nosocomial Infections
Keywords
Intensive Care, Neonatal, Nosocomial Infections, Quality Improvement

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EPIQ sites
Arm Type
Experimental
Arm Description
Use Evidence-based Practice for Improving Quality (EPIQ) method to develop and implement evidence-based practice changes to reduce hospital-acquired infection
Arm Title
Control sites
Arm Type
No Intervention
Arm Description
Continue current practices
Intervention Type
Behavioral
Intervention Name(s)
Evidence-based Practice for Improving Quality (EPIQ) method
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of hospital-acquired infection
Description
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
Time Frame
Three years
Secondary Outcome Measure Information:
Title
Incidence of ventilation associated pneumonia
Time Frame
Three years
Title
Incidence of central line-associated blood stream infection
Time Frame
Three years
Title
Incidence of blood stream infection excluding CLABSI
Time Frame
Three years
Title
Incidence of meningitis
Time Frame
Three years
Title
Incidence of clinical sepsis
Time Frame
Three years
Title
Incidence of urinary tract infections
Time Frame
Three years
Title
Incidence of stage ≥2 necrotizing enterocolitis
Time Frame
Three years
Title
Days on ventilation support
Time Frame
Three years
Title
Days on total parenteral nutrition
Time Frame
Three years
Title
Days on antibiotics
Time Frame
Three years
Title
Days on inotropes
Time Frame
Three years
Title
All cause mortality
Time Frame
Three years
Title
Infection-related mortality
Time Frame
Three years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
120 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun Cao, MD, PHD
Organizational Affiliation
Children's Hospital of Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vibhuti Shah, MD, Msc
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shoo K Lee, MD, PHD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Weiping Wang, MD, PHD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Beijing Children's Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Fujian Maternity and Child Health Care Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Gansu Maternity and Child Health Care Hospital
City
Lanzhou
State/Province
Gansu
Country
China
Facility Name
Shenzhen Maternity and Child Health Care Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
Guangxi Maternity and Child Health Care Hospital
City
Nanning
State/Province
Guangxi
Country
China
Facility Name
Guiyang Children's Hospital
City
Guiyang
State/Province
Guizhou
Country
China
Facility Name
Children's Hospital of Hebei Province
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
Zhengzhou Children's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Hubei Maternity and Child Health Care Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Tongji Hospital Affiliated to Tongji Medical College
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Nanjing Children's Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Nanjing Maternity and Child Health Care Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Suzhou Municipal Hospital
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
Wuxi Maternity and Child Health Care Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
Jiangxi Children's Hospital
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
Jinan Children's Hospital
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Qingdao Maternity and Child Health Care Hospital
City
Qingdao
State/Province
Shandong
Country
China
Facility Name
Shanxi Maternity and Child Health Care Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
Shanxi Maternity and Child Health Care Hospital
City
Xian
State/Province
Shanxi
Country
China
Facility Name
The First Affiliated Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
Country
China
Facility Name
The Second Affiliated Hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
Country
China
Facility Name
Shanghai First Maternity and Child Health Care Hospital
City
Shanghai
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
19667033
Citation
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Results Reference
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PubMed Identifier
24041863
Citation
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Results Reference
background
PubMed Identifier
22451712
Citation
Polin RA, Denson S, Brady MT; Committee on Fetus and Newborn; Committee on Infectious Diseases. Strategies for prevention of health care-associated infections in the NICU. Pediatrics. 2012 Apr;129(4):e1085-93. doi: 10.1542/peds.2012-0145. Epub 2012 Mar 26.
Results Reference
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PubMed Identifier
14510318
Citation
Fanaroff AA, Hack M, Walsh MC. The NICHD neonatal research network: changes in practice and outcomes during the first 15 years. Semin Perinatol. 2003 Aug;27(4):281-7. doi: 10.1016/s0146-0005(03)00055-7.
Results Reference
background
PubMed Identifier
20363446
Citation
Horbar JD, Soll RF, Edwards WH. The Vermont Oxford Network: a community of practice. Clin Perinatol. 2010 Mar;37(1):29-47. doi: 10.1016/j.clp.2010.01.003.
Results Reference
background
PubMed Identifier
35236170
Citation
Peng W, Han J, Li S, Zhang L, Yang C, Guo J, Cao Y. The Association of Human Milk Feeding With Short-Term Health Outcomes Among Chinese Very/Extremely Low Birth Weight Infants. J Hum Lact. 2022 Nov;38(4):670-677. doi: 10.1177/08903344221078237. Epub 2022 Mar 2.
Results Reference
derived
PubMed Identifier
33968845
Citation
Luo N, Jiang S, McNamara PJ, Li X, Guo Y, Wang Y, Han J, Deng Y, Yang Y, Lee SK, Cao Y. Cardiovascular Pharmacological Support Among Preterm Infants in Chinese Referral Center Neonatal Intensive Care Units. Front Pediatr. 2021 Apr 22;9:638540. doi: 10.3389/fped.2021.638540. eCollection 2021.
Results Reference
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PubMed Identifier
32078781
Citation
Peng W, Jiang S, Li S, Xia S, Chen S, Yang Y, Lee SK, Cao Y. Human Milk Feeding Status of Preterm Infants in Neonatal Intensive Care Units in China. J Hum Lact. 2020 May;36(2):283-290. doi: 10.1177/0890334419901265. Epub 2020 Feb 20.
Results Reference
derived

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

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