Reduction of Infection in Neonatal Intensive Care Units Using the Evidence-based Practice for Improving Quality: A Cluster Randomised Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 15,600
- Locations
- 24
- Primary Endpoint
- Incidence of hospital-acquired infection
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- — to 120 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
EPIQ sites
Use Evidence-based Practice for Improving Quality (EPIQ) method to develop and implement evidence-based practice changes to reduce hospital-acquired infection
Intervention: Evidence-based Practice for Improving Quality (EPIQ) method (Behavioral)
Control sites
Continue current practices
Outcomes
Primary Outcomes
Incidence of hospital-acquired infection
Time Frame: 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 Outcomes
- Incidence of ventilation associated pneumonia(Three years)
- Days on antibiotics(Three years)
- Days on inotropes(Three years)
- Incidence of meningitis(Three years)
- Incidence of central line-associated blood stream infection(Three years)
- Days on total parenteral nutrition(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)
- All cause mortality(Three years)
- Infection-related mortality(Three years)