Reduction of Infection in Neonatal Intensive Care Units Using the Evidence-based Practice for Improving Quality: A Cluster Randomised Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Nosocomial Infections
- Sponsor
- Children's Hospital of Fudan University
- Enrollment
- 15600
- Locations
- 23
- Primary Endpoint
- Incidence of hospital-acquired infection
- Status
- Completed
- Last Updated
- 7 years ago
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.
Investigators
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)
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)
- 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)
- Days on inotropes(Three years)
- All cause mortality(Three years)
- Infection-related mortality(Three years)