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

NCT02600195 | Completed DMC

• 1 other identifier: 14-194
• Study Type: interventional
• Target: 15,600
• Locations: 1 country
• Sites: 24

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).

Conditions

Nosocomial Infections

Keywords

Intensive Care, Neonatal; Nosocomial Infections; Quality Improvement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Incidence of ventilation associated pneumonia

  Three years

• Incidence of central line-associated blood stream infection

  Three years

• Incidence of blood stream infection excluding CLABSI

  Three years

• Incidence of meningitis

  Three years

• Incidence of clinical sepsis

  Three years

Study Arms (2)

EPIQ sites

EXPERIMENTAL

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

Control sites

NO INTERVENTION

Continue current practices

Interventions

Evidence-based Practice for Improving Quality (EPIQ) method BEHAVIORAL

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.

EPIQ sites

Eligibility Criteria

• Age: Up to 120 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• China Medical Board: collaborator

Study Sites (24)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Beijing Children's Hospital

Beijing, Beijing Municipality, China

Location

Fujian Maternity and Child Health Care Hospital

Fuzhou, Fujian, China

Location

Gansu Maternity and Child Health Care Hospital

Lanzhou, Gansu, China

Location

Shenzhen Maternity and Child Health Care Hospital

Shenzhen, Guangdong, China

Location

Guangxi Maternity and Child Health Care Hospital

Nanning, Guangxi, China

Location

Guiyang Children's Hospital

Guiyang, Guizhou, China

Location

Children's Hospital of Hebei Province

Shijiazhuang, Hebei, China

Location

Zhengzhou Children's Hospital

Zhengzhou, Henan, China

Location

Hubei Maternity and Child Health Care Hospital

Wuhan, Hubei, China

Location

Tongji Hospital Affiliated to Tongji Medical College

Wuhan, Hubei, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Nanjing Children's Hospital

Nanjing, Jiangsu, China

Location

Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, China

Location

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

Location

Wuxi Maternity and Child Health Care Hospital

Wuxi, Jiangsu, China

Location

Jiangxi Children's Hospital

Nanchang, Jiangxi, China

Location

Jinan Children's Hospital

Jinan, Shandong, China

Location

Qingdao Maternity and Child Health Care Hospital

Qingdao, Shandong, China

Location

Shanxi Maternity and Child Health Care Hospital

Taiyuan, Shanxi, China

Location

Shanxi Maternity and Child Health Care Hospital

Xian, Shanxi, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Location

The Second Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

Location

Shanghai First Maternity and Child Health Care Hospital

Shanghai, China

Location

Related Publications (8)

• 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.

  PMID: 19667033 BACKGROUND

• 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.

  PMID: 24041863 BACKGROUND

• 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.

  PMID: 22451712 BACKGROUND

• 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.

  PMID: 14510318 BACKGROUND

• 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.

  PMID: 20363446 BACKGROUND

• 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.

  PMID: 35236170 DERIVED

• 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.

  PMID: 33968845 DERIVED

• 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.

  PMID: 32078781 DERIVED

MeSH Terms

Conditions

Cross Infection

Interventions

Methods

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 9, 2015
• Study Start: May 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 30, 2018
• Last Updated: August 7, 2018

Record last verified: 2018-08

Locations

CN (24)