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

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ClinicalTrials.gov Identifier: NCT00516360
Recruitment Status : Unknown
Verified August 2007 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was:  Recruiting
First Posted : August 15, 2007
Last Update Posted : May 30, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Catheterization Device: 3.15% chlorhexidine as daily antiseptic on needleless access port Phase 4

Detailed Description:

Catheter-related bloodstream infections (CRBSIs) are a major cause of morbidity and mortality in infants admitted to the NICU. In adults, chlorhexidine used as a skin antiseptic has been shown to reduce the incidence of CRBSIs, and recent evidence indicates the inner surface of long-term central catheters as the likely route of infection. This study will evaluate 3.15% chlorhexidine as the daily catheter hub antiseptic to reduce catheter tip microbial colonization, an indication of high risk for acquiring CRBSI. The purpose of this study is to compare the antiseptic capability of 3.15% chlorhexidine versus isopropyl alcohol in reducing central catheter-related infections in neonates. This study also aims to compare the time to catheter hub microbial colonization in the two groups and to determine the route of catheter tip colonization by comparing cultures taken from the catheter tip, hub, and skin insertion site.

This study will last 1 year. There are no study visits. The placement and removal of the catheter will be determined by the discretion of the attendant caring for the participant. Participants will be randomly assigned to one of two groups. Catheters of Group 1 participants will be treated with 3.15% chlorhexidine at the time of the daily intravenous tubing change. Catheters of Group 2 participants will be treated with isopropyl alcohol. For both groups, cultures of the inner surface of the catheter hub will be performed twice a week, and cultures of the inner surface of the catheter hub, tip, and skin insertion site will be performed upon removal of the catheter.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Chlorhexidine and the Prevention of Central Catheter Related Infections in Neonates
Study Start Date : July 2007
Estimated Primary Completion Date : August 2008
Estimated Study Completion Date : August 2008


Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Chlorhexidien as the antibacterial agent used to cleanse the hub of neonatal central lines
Device: 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
Other Name: Chloraprep
Active Comparator: 2
Isopropyl alcohol as the antibacterial agent used to cleanse the hub of neonatal central lines
Device: 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
Other Name: Chloraprep


Outcome Measures

Primary Outcome Measures :
  1. Catheter tip microbial colonization [ Time Frame: at the time of catheter removal ]

Secondary Outcome Measures :
  1. Time to hub microbial colonization [ Time Frame: at the time of catheter removal ]
  2. Route of catheter tip microbial colonization determined by cultures taken at the catheter hub versus skin [ Time Frame: at the time of catheter removal ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00516360


Contacts
Contact: Erik S. Thingvoll, MD 585-275-1847 erik_thingvoll@urmc.rochester.edu

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Erik S. Thingvoll, MD    585-275-1847    erik_thingvoll@urmc.rochester.edu   
Contact: Carl D'Angio, MD    585-275-5884    carl_dangio@urmc.rochester.edu   
Principal Investigator: Erik S. Thingvoll, MD         
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
University of Rochester
Investigators
Principal Investigator: Erik S. Thingvoll, MD University of Rochester
More Information

Publications:
Responsible Party: Erik Thingvoll, MD, University of Rochester Medical Center
ClinicalTrials.gov Identifier: NCT00516360     History of Changes
Other Study ID Numbers: T32AI007464 ( U.S. NIH Grant/Contract )
00016854
First Posted: August 15, 2007    Key Record Dates
Last Update Posted: May 30, 2008
Last Verified: August 2007

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Catheter related bloodstream infections
Infant, Newborn
Intensive Care Units, Neonatal
Neonatal Central Line Infections

Additional relevant MeSH terms:
Infection
Catheter-Related Infections
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Bacterial Agents
Anti-Infective Agents
Disinfectants
Dermatologic Agents