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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) University of Rochester |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00516360 |
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 | Intervention | Phase |
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Catheterization |
Device: 3.15% chlorhexidine as daily antiseptic on needleless access port |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Chlorhexidine and the Prevention of Central Catheter Related Infections in Neonates |
Estimated Enrollment: | 150 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Chlorhexidien as the antibacterial agent used to cleanse the hub of neonatal central lines
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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
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2: Active Comparator
Isopropyl alcohol as the antibacterial agent used to cleanse the hub of neonatal central lines
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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
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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.
Ages Eligible for Study: | up to 6 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Erik S. Thingvoll, MD | 585-275-1847 | erik_thingvoll@urmc.rochester.edu |
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 |
Principal Investigator: | Erik S. Thingvoll, MD | University of Rochester |
Responsible Party: | University of Rochester Medical Center ( Erik Thingvoll, MD ) |
Study ID Numbers: | T32AI07464, 00016854 |
Study First Received: | August 13, 2007 |
Last Updated: | May 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00516360 |
Health Authority: | United States: Institutional Review Board; United States: Federal Government |
Catheter related bloodstream infections Infant, Newborn Intensive Care Units, Neonatal Neonatal Central Line Infections |
Chlorhexidine Chlorhexidine gluconate |
Anti-Infective Agents Anti-Infective Agents, Local Disinfectants Therapeutic Uses |
Infection Dermatologic Agents Pharmacologic Actions |