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

Reduction of Infection in Neonatal Intensive Care Units Using the Evidence-based Practice for Improving Quality: A Cluster Randomised Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02600195
Enrollment
15600
Registered
2015-11-09
Start date
2015-05-31
Completion date
2018-04-30
Last updated
2018-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nosocomial Infections

Keywords

Intensive Care, Neonatal, Nosocomial Infections, Quality Improvement

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.

Interventions

BEHAVIORALEvidence-based Practice for Improving Quality (EPIQ) method

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.

Sponsors

China Medical Board
CollaboratorOTHER
Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 120 Days
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)

Design outcomes

Primary

MeasureTime frameDescription
Incidence of hospital-acquired infectionThree yearsCombined 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

MeasureTime frame
Incidence of central line-associated blood stream infectionThree years
Incidence of blood stream infection excluding CLABSIThree years
Incidence of meningitisThree years
Incidence of clinical sepsisThree years
Incidence of urinary tract infectionsThree years
Incidence of stage ≥2 necrotizing enterocolitisThree years
Incidence of ventilation associated pneumoniaThree years
Days on total parenteral nutritionThree years
Days on antibioticsThree years
Days on inotropesThree years
All cause mortalityThree years
Infection-related mortalityThree years
Days on ventilation supportThree years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026