Reducing vancomycin use in newborn intensive care
Implementing Vancomycin Reducing Practices (VRP) in Preterm Infants
This trial tests whether giving outside support to Level III NICUs helps staff follow vancomycin-reduction practices for newborns at risk of late-onset sepsis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 13 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 13 sites (Modesto, California and 12 other locations) |
| Trial ID | NCT06772675 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, cluster-randomized implementation trial in Level III NICUs affiliated with Kaiser Permanente Northern California or the Children’s Hospital of Philadelphia network. Participating sites are randomized to receive external facilitation or usual implementation support, with interventions aimed at hospital staff such as identifying local champions, educational outreach, unit-level audit and feedback, and a clinical decision support tool. The primary outcome is center-level fidelity to the core components of vancomycin-reducing practices, with the goal of changing prescribing behavior across the unit. Data will be collected at the site level to compare adoption and sustainment between arms.
Who should consider this trial
Good fit: Ideal participants are Level III NICUs affiliated with Kaiser Permanente Northern California or the Children’s Hospital of Philadelphia Newborn Care Network that agree to be recruited into the trial.
Not a fit: NICUs that are not Level III, not part of the specified networks, or not enrolled in the study — and individual infants who need vancomycin for proven infections — are unlikely to receive benefit from the intervention.
Why it matters
Potential benefit: If successful, the approach could reduce unnecessary vancomycin exposure in newborns, lowering drug-related harms and antimicrobial resistance.
How similar studies have performed: Similar stewardship approaches (champions, audit and feedback, decision support) have improved antibiotic use in other hospital settings, though direct evidence in NICUs is more limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Modesto, California and 12 other locations
- Kaiser Permanente Modesto Medical Center — Modesto, California, United States (Recruiting)
- Kaiser Permanente East Bay - Oakland Medical Center — Oakland, California, United States (Recruiting)
- Kaiser Permanente Roseville Medical Center — Roseville, California, United States (Recruiting)
- Kaiser Permanente San Francisco Medical Center — San Francisco, California, United States (Recruiting)
- Kaiser Permanente San Leandro Medical Center — San Leandro, California, United States (Recruiting)
- Kaiser Permanente Santa Clara Medical Center — Santa Clara, California, United States (Recruiting)
- Kaiser Permanente Walnut Creek Medical Center — Walnut Creek, California, United States (Recruiting)
- Medical Center of Princeton — Plainsboro, New Jersey, United States (Recruiting)
- Virtua Voorhees — Voorhees Township, New Jersey, United States (Recruiting)
- Lancaster General Hospital — Lancaster, Pennsylvania, United States (Recruiting)
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Pennsylvania Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
- Chester County Hospital — West Chester, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Sagori Mukhopadhyay, MD, MMSc — Children's Hospital of Philadelphia
- Study coordinator: Kayla Gilpin
- Email: kayla.gilpin@pennmedicine.upenn.edu
- Phone: 215-573-3976
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.