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Completed

NCT Number: NCT03079245

Improving Antimicrobial Prescribing Practices in the Neonatal ICU

To determine if 3 randomly assigned bundles of stewardship interventions would reduce overall and inappropriate antimicrobial use in the neonatal intensive care unit (NICU), a pre-post study was performed in 4 NICUs.

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Key information

Conditions

Infants in Neonatal Intensive Care Units

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christiana Care Health Sciences, Wilmington, Delaware, United States

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About this study

Antimicrobial stewardship can improve the safety and quality of healthcare, reduce antimicrobial resistance, and reduce healthcare costs. However, the optimal strategies for the NICU population are unknown and few studies have evaluated the impact of stewardship in this population. To determine if 3 randomly assigned bundles of stewardship interventions would reduce overall and inappropriate antimicrobial use in the NICU. The investigators hypothesized that the bundle using all three interdisciplinary antimicrobial stewardship strategies (education, computer decision support and prescriber audit and feedback) would more effectively reduce overall and inappropriate antimicrobial use compared to usual care. A pre-post intervention study (one baseline year without interventions - May 1, 2009 - April 30, 2010, followed by two years of interventions - May 1, 2010 - April 30, 2012) was performed in 4 academically affiliated, level III NICUs. The sites were randomly assigned to usual care, one intervention, two interventions, or three interventions.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • infants admitted to study NICUs <7 days of age who remained hospitalized 4 days or more days

Exclusion criteria

  • Infants admitted to study NICUs 7 days of age and older who were hospitalized less than 4 days

Treatment and study plan

Education Plus (E+)

Other

Education Plus was an intervention developed by the study team based on the Center for Disease Control (CDC) 12 Step Campaign to Prevent Antimicrobial Resistance in Healthcare Settings. The study team provided Education Plus quarterly to prescribers at the three sites (NICU A, B, C) randomized to this intervention. Examples of topics presented were an overview of antimicrobial stewardship principles, epidemiology of healthcare-associated infections (HAIs), prevention of surgical site infections, antimicrobial susceptibility testing, and pharmacokinetic principles. Educational formats included didactic lectures, participation via the audience response system, case vignettes, and panel discussions.

Clinical Decision Support

Other

The CDS tool was an intervention developed in consultation with neonatologists and pediatric infectious disease physicians from NICU A and B. Algorithms for empiric and targeted antimicrobial therapy for common pathogens and common clinical scenarios using local antimicrobial susceptibility patterns were developed. The CDS tool also provided additional components to facilitate antimicrobial prescribing, e.g., patient weight, day of life, previous culture results, antimicrobial orders, and selected laboratory results including white blood cell and platelet count, C-reactive protein, creatinine, and therapeutic drug levels. NICUs A and B also received E+

Prescriber Audit and Feedback

Other

The prescriber audit and feedback (PAF) intervention was developed by the study team which held focus groups with neonatologists at NICU A (the site randomized to this intervention) to determine the feedback parameters and feedback format as previously described. Neonatologists at NICU A were provided aggregated prescribing data bimonthly that described inappropriate use as described below and prolonged therapy (>7 days) for culture-negative late onset sepsis. NICU A also received CDS and E+.

Primary outcomes

  1. Overall Antimicrobial Use measured as days of therapy per 100 patient-days

    Time frame: Through study completion for 2 years

    The indications for initiation of intravenous antimicrobials were categorized as initiation of empiric therapy (antibiotics started prior to culture results), definitive therapy (culture results available prior to initiation of antibiotics), or prophylaxis (e.g., antibiotics for postoperative prophylaxis).

Secondary outcomes

  1. Length of therapy per 100 patient-days

    Time frame: Through study completion for 2 years

    2 agents received on same day counted as one day

  2. Inappropriate Antimicrobial Use

    Time frame: Through study completion for 2 years

    Determined on 4th calendar-day of treatment as redundant therapy and failure to target the pathogen

  3. Number of infants initiated on ineffective empiric therapy

    Time frame: Through study completion for 2 years

    Initiation of ineffective empiric therapy for infants thought to be infected

  4. Proportion of infants treated for culture negative late onset sepsis

    Time frame: Through study completion for 2 years

    The proportion of infants treated for culture negative late onset sepsis lasting more than 7 days

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Children's Hospital of Philadelphia
  • Christiana Care Health Services
  • National Institute of Nursing Research (NINR)
  • Weill Medical College of Cornell University

Registry information

Official study title

Improving Antimicrobial Prescribing Practices in the Neonatal Intensive Care Unit

Acronym: iNAP

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 14, 2017
Registry last updated
Mar 14, 2017

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.