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Antiseptic

Study of Chlorhexidine as the Hub Antiseptic to Prevent Catheter Related Infections in Newborn Infants

Phase 4
Waitlist Available
Led By Erik S. Thingvoll, MD
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

The purpose of this study is to prevent catheter-related infections in newborn infants admitted to the Neonatal Intensive Care Unit (NICU). This study will compare the effectiveness of daily chlorhexidine versus isopropyl alcohol in preventing the growth of microbes in catheters.

Eligible Conditions
  • Catheterization

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 1Experimental Treatment1 Intervention
Chlorhexidien as the antibacterial agent used to cleanse the hub of neonatal central lines
Group II: 2Active Control1 Intervention
Isopropyl alcohol as the antibacterial agent used to cleanse the hub of neonatal central lines

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,336 Previous Clinical Trials
5,382,684 Total Patients Enrolled
University of RochesterOTHER
872 Previous Clinical Trials
549,947 Total Patients Enrolled
Erik S. Thingvoll, MDPrincipal InvestigatorUniversity of Rochester
~8 spots leftby Dec 2025
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