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

Chlorhexidine and the Prevention of Central Catheter Related Infections in Neonates

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.

Study Overview

• Status: Unknown
• Conditions: Catheterization
• Intervention / Treatment: Device: 3.15% chlorhexidine as daily antiseptic on needleless access port

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Erik S. Thingvoll, MD; Phone Number: 585-275-1847; Email: erik_thingvoll@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester
      • Contact: Erik S. Thingvoll, MD; Phone Number: 585-275-1847; Email: erik_thingvoll@urmc.rochester.edu
      • Contact: Carl D'Angio, MD; Phone Number: 585-275-5884; Email: carl_dangio@urmc.rochester.edu
      • Principal Investigator: Erik S. Thingvoll, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Chloraprep

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Catheter tip microbial colonization	at the time of catheter removal

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to hub microbial colonization	at the time of catheter removal
Route of catheter tip microbial colonization determined by cultures taken at the catheter hub versus skin	at the time of catheter removal

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: University of Rochester
• Investigators: Principal Investigator: Erik S. Thingvoll, MD, University of Rochester

Publications and helpful links

General 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. 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Anticipated): August 1, 2008
• Study Completion (Anticipated): August 1, 2008

Study Registration Dates

• First Submitted: August 13, 2007
• First Submitted That Met QC Criteria: August 13, 2007
• First Posted (Estimate): August 15, 2007

Study Record Updates

• Last Update Posted (Estimate): May 30, 2008
• Last Update Submitted That Met QC Criteria: May 28, 2008
• Last Verified: August 1, 2007

More Information

Terms related to this study

• Keywords: Infant, Newborn; Intensive Care Units, Neonatal; Catheter related bloodstream infections; Neonatal Central Line Infections
• Additional Relevant MeSH Terms: Infections; Catheter-Related Infections; Anti-Infective Agents; Disinfectants; Chlorhexidine; Anti-Infective Agents, Local
• Other Study ID Numbers: T32AI007464 (U.S. NIH Grant/Contract); 00016854