Study of Chlorhexidine as the Hub Antiseptic to Prevent Catheter Related Infections in Newborn Infants
NCT ID: NCT00516360
Last Updated: 2008-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
150 participants
INTERVENTIONAL
2007-07-31
2008-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
Chlorhexidien as the antibacterial agent used to cleanse the hub of neonatal central lines
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
2
Isopropyl alcohol as the antibacterial agent used to cleanse the hub of neonatal central lines
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Months
ALL
No
Sponsors
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University of Rochester
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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University of Rochester Medical Center
Principal Investigators
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Erik S. Thingvoll, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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University of Rochester
Rochester, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Erik S. Thingvoll, MD
Role: primary
Carl D'Angio, MD
Role: backup
References
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Garland JS, Alex CP, Mueller CD, Otten D, Shivpuri C, Harris MC, Naples M, Pellegrini J, Buck RK, McAuliffe TL, Goldmann DA, Maki DG. A randomized trial comparing povidone-iodine to a chlorhexidine gluconate-impregnated dressing for prevention of central venous catheter infections in neonates. Pediatrics. 2001 Jun;107(6):1431-6. doi: 10.1542/peds.107.6.1431.
Garland JS, Henrickson K, Maki DG; 2002 Hospital Infection Control Practices Advisory Committee Centers for Disease Control and Prevention. The 2002 Hospital Infection Control Practices Advisory Committee Centers for Disease Control and Prevention guideline for prevention of intravascular device-related infection. Pediatrics. 2002 Nov;110(5):1009-13. doi: 10.1542/peds.110.5.1009. No abstract available.
Other Identifiers
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00016854
Identifier Type: -
Identifier Source: secondary_id