Study of Chlorhexidine as the Hub Antiseptic to Prevent Catheter Related Infections in Newborn Infants - Full Text View

Purpose

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
Catheterization	Device: 3.15% chlorhexidine as daily antiseptic on needleless access port	Phase IV

ChemIDplus related topics:

Chlorhexidine Chlorhexidine digluconate

U.S. FDA Resources

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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Catheter tip microbial colonization [ Time Frame: at the time of catheter removal ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to hub microbial colonization [ Time Frame: at the time of catheter removal ] [ Designated as safety issue: No ]
Route of catheter tip microbial colonization determined by cultures taken at the catheter hub versus skin [ Time Frame: at the time of catheter removal ] [ Designated as safety issue: No ]

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
1: Experimental 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
2: Active Comparator 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

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.

Eligibility

Ages Eligible for Study:	up to 6 Months
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

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.

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. No abstract available.

Responsible Party:	University of Rochester Medical Center ( Erik Thingvoll, MD )
Study ID Numbers:	T32AI07464, 00016854
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

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

Study placed in the following topic categories:

Chlorhexidine

Chlorhexidine gluconate

Additional relevant MeSH terms:

Anti-Infective Agents

Anti-Infective Agents, Local

Disinfectants

Therapeutic Uses

Infection

Dermatologic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008

Sponsors and Collaborators:	National Institute of Allergy and Infectious Diseases (NIAID) University of Rochester
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00516360