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Vancomycin Reduction Practices (VRP) in the NICU

Implementing Vancomycin Reducing Practices (VRP) in Preterm Infants

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06772675
Enrollment
13
Registered
2025-01-13
Start date
2025-06-02
Completion date
2027-09-30
Last updated
2025-12-24

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

Conditions

Antibiotic Stewardship, Neonatal Sepsis, Late-Onset, Vancomycin

Keywords

implementation study

Brief summary

This multi-center, cluster randomized study aimed at improving implementation of vancomycin reducing practices (VRP) in neonatal intensive care units (NICUs). Sites will be recruited and randomized to receive either external facilitation or no external facilitation to assess the effect on center-level fidelity to the core components of VRP implementation. Interventions available to both study arms are directed at hospital staff and includes identification of local champions, educational outreach, unit-level audit & feedback, and use of a clinical decision support tool.

Interventions

Designated external facilitators will conduct monthly meetings with local champions at each site. Designated facilitators will follow the developed facilitation guide, that includes content area to cover in each meeting, case scenarios as examples, and tips on how to communicate and support the internal facilitators. The goal is to enable problem-solving and support the local champion in implementing VRP with fidelity

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Cluster randomized study of external facilitation as an implementation strategy

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Level III NICU * Affiliated with Kaiser Permanente Northern California (KPNC) or Children's Hospital of Philadelphia Newborn Care Network (CNBCN) * Recruited by study team

Exclusion criteria

* Site not recruited for the study

Design outcomes

Primary

MeasureTime frameDescription
Fidelity of VRP use2.5 years - From beginning of implementation phase to the end of the sustainment phaseProportion of late onset sepsis (LOS) evaluations performed with high fidelity. High fidelity is defined when the evaluation follows all three core components of VRP use.

Secondary

MeasureTime frameDescription
Appropriateness/acceptability2.5 years - From beginning of implementation phase to the end of the sustainment phaseResponse to questions about whether vancomycin reducing practices (VRP) was agreeable and/or a good fit for the unit measured using validated instruments comprising of 5-point Likert scales (Weiner et al). Participants are offered options ranging from completely disagree (1) to completely agree (5), with higher scores indicating a higher degree of acceptability or feasibility.

Countries

United States

Contacts

Primary ContactKayla Gilpin
kayla.gilpin@pennmedicine.upenn.edu215-573-3976
Backup ContactMorgan Gabbert
gabbertm@chop.edu267-233-3150

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026