Vancomycin Use for Neonatal Sepsis

Recruiting at 12 trial locations

Overseen By Hanna Rosewood

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Site not recruited, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

13 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Sagori Mukhopadhyay, MD, MMSc

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for Level III Neonatal Intensive Care Units (NICUs) affiliated with Kaiser Permanente Northern California or Children's Hospital of Philadelphia Newborn Care Network. NICUs must be recruited by the study team to participate.

Inclusion Criteria

My baby needs or is in a Level III NICU.

I was approached by the study team to participate.

I am a member of Kaiser Permanente Northern California or affiliated with Children's Hospital of Philadelphia Newborn Care Network.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Sites are 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.

2.5 years

Sustainment

Continued monitoring and support to ensure the fidelity of VRP use and assess the appropriateness and acceptability of the practices.

2.5 years

Follow-up

Participants are monitored for safety and effectiveness after the implementation phase.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• External Facilitation

Trial Overview The study tests if external facilitation helps NICUs implement vancomycin reducing practices better than those without such support. It involves local champions, staff education, unit-level audits & feedback, and a clinical decision support tool.

How Is the Trial Designed?

Group I: Sites receiving external facilitation Experimental Treatment 1 Intervention

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

Group II: Sites not receiving external facilitation Active Control 1 Intervention

Sites will not receive guidance from an external facilitator.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+