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Completed

NCT Number: NCT02600195

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

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).

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Key information

Conditions

Nosocomial Infections Cross Infection Disease Attributes Iatrogenic Disease Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 120 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Evidence-based Practice for Improving Quality (EPIQ) method

Behavioral

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.

Primary outcomes

  1. 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

  1. Incidence of ventilation associated pneumonia

    Time frame: Three years

  2. Incidence of central line-associated blood stream infection

    Time frame: Three years

  3. Incidence of blood stream infection excluding CLABSI

    Time frame: Three years

  4. Incidence of meningitis

    Time frame: Three years

  5. Incidence of clinical sepsis

    Time frame: Three years

  6. Incidence of urinary tract infections

    Time frame: Three years

  7. Incidence of stage ≥2 necrotizing enterocolitis

    Time frame: Three years

  8. Days on ventilation support

    Time frame: Three years

  9. Days on total parenteral nutrition

    Time frame: Three years

  10. Days on antibiotics

    Time frame: Three years

  11. Days on inotropes

    Time frame: Three years

  12. All cause mortality

    Time frame: Three years

  13. Infection-related mortality

    Time frame: Three years

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

  • China Medical Board

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 9, 2015
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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