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

Nosocomial Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600195
• Other study ID #: 14-194
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: April 30, 2018

Study information

• Verified date: August 2018
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15600
• Est. completion date: April 30, 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 120 Days

Eligibility

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)

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Infection
• Nosocomial Infections

Intervention

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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	China Medical Board

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View Citation

Lee SK, Aziz K, Singhal N, Cronin CM, James A, Lee DS, Matthew D, Ohlsson A, Sankaran K, Seshia M, Synnes A, Walker R, Whyte R, Langley J, MacNab YC, Stevens B, von Dadelszen P. Improving the quality of care for infants: a cluster randomized controlled trial. CMAJ. 2009 Oct 13;181(8):469-76. doi: 10.1503/cmaj.081727. Epub 2009 Aug 10. — View 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. Review. — View Citation

Zhou Q, Lee SK, Jiang SY, Chen C, Kamaluddeen M, Hu XJ, Wang CQ, Cao Y. Efficacy of an infection control program in reducing ventilator-associated pneumonia in a Chinese neonatal intensive care unit. Am J Infect Control. 2013 Nov;41(11):1059-64. doi: 10.1016/j.ajic.2013.06.007. Epub 2013 Sep 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Three years
Secondary	Incidence of ventilation associated pneumonia		Three years
Secondary	Incidence of central line-associated blood stream infection		Three years
Secondary	Incidence of blood stream infection excluding CLABSI		Three years
Secondary	Incidence of meningitis		Three years
Secondary	Incidence of clinical sepsis		Three years
Secondary	Incidence of urinary tract infections		Three years
Secondary	Incidence of stage =2 necrotizing enterocolitis		Three years
Secondary	Days on ventilation support		Three years
Secondary	Days on total parenteral nutrition		Three years
Secondary	Days on antibiotics		Three years
Secondary	Days on inotropes		Three years
Secondary	All cause mortality		Three years
Secondary	Infection-related mortality		Three years