Recruiting

Chlorhexidine

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT00516360

Conditions

Catheterization

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

3.15% chlorhexidine as daily antiseptic on needleless access port

Study Details

Brief 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.

Conditions

Catheterization

Study ID

NCT00516360

Start date

Jul, 2007

Status verified date

Aug, 2007

Completion date

Aug, 2008

Anticipated

Primary completion date

Aug, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Admitted to the NICU
  • Umbilical vein catheter or peripherally inserted central venous catheter (PICC) anticipated to be in place for more than 48 hours
  • Parent or guardian able to give informed consent prior to first hyperalimentation and total parenteral nutrition tubing change

Exclusion Criteria:

  • Known CRBSI-positive blood culture at the time of catheter line placement.
  • Not expected to survive for more than 48 hours
  • Broviac or any other surgically-placed central catheters
  • Any condition that, as determined by the investigator, would interfere with evaluation of the line or be a potential health risk to the participant

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 1

Chlorhexidien as the antibacterial agent used to cleanse the hub of neonatal central lines

active comparator: 2

Isopropyl alcohol as the antibacterial agent used to cleanse the hub of neonatal central lines

Interventions

3.15% chlorhexidine as daily antiseptic on needleless access port

3.15% chlorhexidine as daily antiseptic on needleless access port. 1 wipe used to cleanse port each time the port is accessed

Primary outcome measure

  • Catheter tip microbial colonization [ Time Frame: at the time of catheter removal ]

Central Contacts and Locations

Central contacts

Erik S. Thingvoll, MD

585-275-1847erik_thingvoll@urmc.rochester.edu

Locations

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Erik S. Thingvoll, MD

585-275-1847erik_thingvoll@urmc.rochester.edu

Carl D'Angio, MD

585-275-5884carl_dangio@urmc.rochester.edu

Principal Investigator:

Erik S. Thingvoll, MD

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

May 30, 2008

Last verified

Aug, 2007

Keywords

  • Catheter related bloodstream infections
  • Infant, Newborn
  • Intensive Care Units, Neonatal
  • Neonatal Central Line Infections

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2008-05-30.