An interventional study of External Facilitation in Antibiotic Stewardship, Neonatal Sepsis, Late-Onset and Vancomycin, sponsored by Children's Hospital of Philadelphia. Recruiting at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Other
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.
192 studies on the registry are indexed under Neonatal Sepsis; 41 are open to participants now.
This study's planned enrollment of 13 is below the median of 181 across 102 interventional studies indexed under Neonatal Sepsis.
Browse Neonatal Sepsis studies →Children's Hospital of Philadelphia is the lead sponsor of 489 studies on the registry; 90 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Sites will receive guidance from an external facilitator to support uptake of the VRP.
Behavioral: External Facilitation
Sites will not receive guidance from an external facilitator.
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
Fidelity of VRP use
Proportion 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.
Time frame: 2.5 years - From beginning of implementation phase to the end of the sustainment phase
Appropriateness/acceptability
Response 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.
Time frame: 2.5 years - From beginning of implementation phase to the end of the sustainment phase
Plan to share: Undecided — Participants here are the clinicians at the sites randomized to external facilitation. The investigators obtain survey (de-identified) and interview data from representative group of the clinicians. Since the investigators will be gathering richly detailed qualitative data that, even if de-identified of names or locations, can still be linked back to sites or individuals, the investigators will not share interview data for secondary analysis or use beyond the purposes of the proposal. The investigators will maintain de-identified (for both site and respondent identifiers) survey output that can be shared upon appropriate request to the principal investigator.
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Sep 2027, 27 months after the start.
Of 30 interventional studies with no phase under Neonatal Sepsis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's planned 27 months is above that.
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