Vancomycin Use for Neonatal Sepsis

Recruiting at 13 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 trial explores better ways to use vancomycin, an antibiotic, for treating newborns with sepsis in neonatal intensive care units (NICUs). Researchers are testing whether external facilitation, where outside experts assist hospital staff, improves vancomycin use compared to not having this support. The goal is to determine if this assistance helps hospitals adhere more closely to best practices. This trial suits NICUs within specific hospital networks that have received invitations to participate. As an unphased trial, it offers a unique opportunity to contribute to improving treatment practices for newborns in NICUs.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this protocol is safe for neonatal intensive care units?

Previous studies have shown that external facilitation safely improves healthcare practices. This method helps hospital staff find better ways to treat patients, such as reducing unnecessary antibiotic use. Importantly, external facilitation does not involve new medications or direct medical treatments. Instead, it provides hospital staff with tools and guidance. Therefore, the facilitation itself poses no direct safety concerns for patients. It primarily aids hospitals in adopting better practices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores whether external facilitation can improve the implementation of vancomycin protocols for neonatal sepsis. Unlike traditional methods that rely solely on internal hospital resources, external facilitation involves expert guidance to enhance protocol adherence and effectiveness. This could lead to more consistent and effective use of vancomycin, potentially improving outcomes for newborns with sepsis. By examining the impact of this method, the trial aims to uncover new strategies for optimizing treatment in critical care settings.

What evidence suggests that external facilitation is effective for improving vancomycin reducing practices in NICUs?

Research has shown that using antibiotics early and effectively is crucial for treating newborns with sepsis, preventing long-term health issues. In this trial, some sites will receive external facilitation to support the uptake of the Vancomycin Reduction Protocol (VRP). Studies have found that healthcare teams receiving outside support are more likely to follow practices that reduce unnecessary antibiotic use. This support helps manage newborns with suspected sepsis more efficiently by reducing unneeded tests and treatments. Streamlined practices lead to better outcomes for newborns. By focusing on these improvements, hospitals can provide safer and more effective care for infants at risk of sepsis. ^{1 2 6 7 8}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11761862/

Neonatal Sepsis: A Comprehensive Review - PMC Early initiation of antibiotics in septic newborns is vital, as neonatal sepsis can lead to an increased risk of lifelong complications, ...

2. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1002/ijgo.15725

Outcomes of interventions in neonatal sepsis: A systematic ... This study reviews outcomes considered important in neonatal sepsis by stakeholders such as parents and healthcare providers, ...

3. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00351-7/fulltext

Safety and effectiveness of the early-onset sepsis ... The co-primary superiority outcome assessed the reduction of participants starting antibiotic therapy for suspected EOS within 24 h postpartum.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10605684/

Barriers and Facilitators to the Implementation of the Early ... This study aimed to identify key barriers and facilitators to inform an implementation strategy. A multicenter cross-sectional survey was carried out.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0021755723001031

Improved efficiency in the management of newborns with ... During the second period, tests to rule out sepsis were reduced by 34.0 % (RR, 95 %CI): 0.66 (0.61, 0.71), blood cultures by 13.1 %: 0.87 (0.77, 0.98), hospital ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11370662/

a before-and-after study about neonatal sepsis - PMC The study included 399 neonates over three years, comparing pre- and post-protocol outcomes. Data collection focused on maternal and neonatal ...

7. journals.plos.org journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1004179

A global neonatal sepsis observational cohort study (NeoOBS) Mortality among infants with a pathogen-positive baseline culture was 17.7% (99/564; 95% CI 14.7% to 21.1%) compared with 9.9% (250/2,631; 95% CI 8.8% to 11.2%) ...

8. medrxiv.org medrxiv.org/content/10.1101/2025.03.31.25324838v1.full-text

Facilitators and barriers when implementing antibiotic ... In high-income countries, 1.2% to 12.5% of liveborn neonates is treated for suspected early-onset sepsis (EOS), which is up to 58 times as much ...