Reduction of Infection in Neonatal Intensive Care Units Using the Evidence-based Practice for Improving Quality
- Conditions
- Nosocomial Infections
- Interventions
- Behavioral: Evidence-based Practice for Improving Quality (EPIQ) method
- Registration Number
- NCT02600195
- Lead Sponsor
- Children's Hospital of Fudan University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15600
- 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
- Infants with major congenital anomalies
- Infants who are moribund on admission (a decision is made to provide only palliative care)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EPIQ sites Evidence-based Practice for Improving Quality (EPIQ) method Use Evidence-based Practice for Improving Quality (EPIQ) method to develop and implement evidence-based practice changes to reduce hospital-acquired infection
- Primary Outcome Measures
Name Time Method Incidence of hospital-acquired infection 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
- Secondary Outcome Measures
Name Time Method Days on antibiotics Three years Days on total parenteral nutrition Three years Incidence of ventilation associated pneumonia Three years Incidence of meningitis Three years Incidence of central line-associated blood stream infection Three years Incidence of blood stream infection excluding CLABSI Three years Incidence of clinical sepsis Three years Incidence of urinary tract infections Three years Incidence of stage ≥2 necrotizing enterocolitis Three years Days on ventilation support Three years Days on inotropes Three years All cause mortality Three years Infection-related mortality Three years
Trial Locations
- Locations (23)
Shanxi Maternity and Child Health Care Hospital
🇨🇳Xian, Shanxi, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Gansu Maternity and Child Health Care Hospital
🇨🇳Lanzhou, Gansu, China
Hubei Maternity and Child Health Care Hospital
🇨🇳Wuhan, Hubei, China
Nanjing Children's Hospital
🇨🇳Nanjing, Jiangsu, China
Nanjing Maternity and Child Health Care Hospital
🇨🇳Nanjing, Jiangsu, China
Guiyang Children's Hospital
🇨🇳Guiyang, Guizhou, China
Wuxi Maternity and Child Health Care Hospital
🇨🇳Wuxi, Jiangsu, China
Beijing Children's Hospital
🇨🇳Beijing, Beijing, China
Tongji Hospital Affiliated to Tongji Medical College
🇨🇳Wuhan, Hubei, China
Shenzhen Maternity and Child Health Care Hospital
🇨🇳Shenzhen, Guangdong, China
Guangxi Maternity and Child Health Care Hospital
🇨🇳Nanning, Guangxi, China
Children's Hospital of Hebei Province
🇨🇳Shijiazhuang, Hebei, China
Zhengzhou Children's Hospital
🇨🇳Zhengzhou, Henan, China
Fujian Maternity and Child Health Care Hospital
🇨🇳Fuzhou, Fujian, China
Jiangxi Children's Hospital
🇨🇳Nanchang, Jiangxi, China
Jinan Children's Hospital
🇨🇳Jinan, Shandong, China
Qingdao Maternity and Child Health Care Hospital
🇨🇳Qingdao, Shandong, China
Shanghai First Maternity and Child Health Care Hospital
🇨🇳Shanghai, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Suzhou Municipal Hospital
🇨🇳Suzhou, Jiangsu, China
The Second Affiliated Hospital of Wenzhou Medical College
🇨🇳Wenzhou, Zhejiang, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China