Vancomycin Reduction Practices (VRP) in the NICU

NCT ID: NCT06772675

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-02

Study Completion Date

2027-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Antibiotic Stewardship Neonatal Sepsis, Late-Onset Vancomycin

Keywords

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implementation study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized study of external facilitation as an implementation strategy
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Sites receiving external facilitation

Sites will receive guidance from an external facilitator to support uptake of the VRP.

Group Type EXPERIMENTAL

External Facilitation

Intervention Type BEHAVIORAL

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

Sites not receiving external facilitation

Sites will not receive guidance from an external facilitator.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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External Facilitation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Sagori Mukhopadhyay

Principal Investigator, Attending Neonatologist, Associate Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sagori Mukhopadhyay, MD, MMSc

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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Kaiser Permanente Modesto Medical Center

Modesto, California, United States

Site Status RECRUITING

Kaiser Permanente East Bay - Oakland Medical Center

Oakland, California, United States

Site Status RECRUITING

Kaiser Permanente Roseville Medical Center

Roseville, California, United States

Site Status RECRUITING

Kaiser Permanente San Francisco Medical Center

San Francisco, California, United States

Site Status RECRUITING

Kaiser Permanente San Leandro Medical Center

San Leandro, California, United States

Site Status RECRUITING

Kaiser Permanente Santa Clara Medical Center

Santa Clara, California, United States

Site Status RECRUITING

Kaiser Permanente Walnut Creek Medical Center

Walnut Creek, California, United States

Site Status RECRUITING

Medical Center of Princeton

Plainsboro, New Jersey, United States

Site Status RECRUITING

Virtua Voorhees

Voorhees Township, New Jersey, United States

Site Status RECRUITING

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Site Status RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Chester County Hospital

West Chester, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kayla Gilpin

Role: CONTACT

Phone: 215-573-3976

Email: [email protected]

Morgan Gabbert

Role: CONTACT

Phone: 267-233-3150

Email: [email protected]

Facility Contacts

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Dr. Michael W. Kuzniewicz

Role: primary

Dr. Michael W. Kuzniewicz

Role: primary

Dr. Michael W. Kuzniewicz

Role: primary

Dr. Michael W. Kuzniewicz

Role: primary

Dr. Michael W. Kuzniewicz

Role: primary

Dr. Michael W. Kuzniewicz

Role: primary

Dr. Michael W. Kuzniewicz

Role: primary

Dr. Sagori Mukhopadhyay

Role: primary

Dr. Sagori Mukhopadhyay

Role: primary

Dr. Sagori Mukhopadhyay

Role: primary

Dr. Sagori Mukhopdhyay

Role: primary

Dr. Sagori Mukhopadhyay

Role: primary

Dr. Sagori Mukhopadhyay

Role: primary

Other Identifiers

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GRT-00003877

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

24-021976

Identifier Type: -

Identifier Source: org_study_id