Clinical trial NCT02600195: 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
Overall status: COMPLETED
Phase: NA
Conditions: Nosocomial Infections
Keywords: Intensive Care, Neonatal
Nosocomial Infections
Quality Improvement
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: China Medical Board
First posted: 2015-11-09
Enrollment: 15600
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Incidence of hospital-acquired infection
timeFrame: Three years
Secondary outcomes:
measure: Incidence of ventilation associated pneumonia
timeFrame: Three years
measure: Incidence of central line-associated blood stream infection
timeFrame: Three years
measure: Incidence of blood stream infection excluding CLABSI
timeFrame: Three years
measure: Incidence of meningitis
timeFrame: Three years
measure: Incidence of clinical sepsis
timeFrame: Three years
measure: Incidence of urinary tract infections
timeFrame: Three years
measure: Incidence of stage ≥2 necrotizing enterocolitis
timeFrame: Three years
measure: Days on ventilation support
timeFrame: Three years
measure: Days on total parenteral nutrition
timeFrame: Three years
measure: Days on antibiotics
timeFrame: Three years
measure: Days on inotropes
timeFrame: Three years
measure: All cause mortality
timeFrame: Three years
measure: Infection-related mortality
timeFrame: Three years
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Children's Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Maternity and Child Health Care Hospital
state: Fujian
city: Lanzhou
country: China
facility: Gansu Maternity and Child Health Care Hospital
state: Gansu
city: Shenzhen
country: China
facility: Shenzhen Maternity and Child Health Care Hospital
state: Guangdong
city: Nanning
country: China
facility: Guangxi Maternity and Child Health Care Hospital
state: Guangxi
city: Guiyang
country: China
facility: Guiyang Children's Hospital
state: Guizhou
city: Shijiazhuang
country: China
facility: Children's Hospital of Hebei Province
state: Hebei
city: Zhengzhou
country: China
facility: Zhengzhou Children's Hospital
state: Henan
city: Wuhan
country: China
facility: Hubei Maternity and Child Health Care Hospital
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Nanjing Children's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Maternity and Child Health Care Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Maternity and Child Health Care Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Children's Hospital
state: Jiangxi
city: Jinan
country: China
facility: Jinan Children's Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Maternity and Child Health Care Hospital
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Maternity and Child Health Care Hospital
state: Shanxi
city: Xian
country: China
facility: Shanxi Maternity and Child Health Care Hospital
state: Shanxi
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical College
state: Zhejiang
city: Shanghai
country: China
facility: Shanghai First Maternity and Child Health Care Hospital
Study officials:
affiliation: Children's Hospital of Fudan University
name: Yun Cao, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Vibhuti Shah, MD, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Shoo K Lee, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Weiping Wang, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.