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

NCT00516360 | Unknown Phase 4 DMC

• 2 other identifiers: T32AI00746400016854
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheterization

Keywords

Catheter related bloodstream infections; Infant, Newborn; Intensive Care Units, Neonatal; Neonatal Central Line Infections

Outcome Measures

Primary Outcomes (1)

• Catheter tip microbial colonization

  at the time of catheter removal

Secondary Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

3.15% chlorhexidine as daily antiseptic on needleless access port DEVICE

3.15% chlorhexidine as daily antiseptic on needleless access port. 1 wipe used to cleanse port each time the port is accessed

Also known as: Chloraprep

1; 2

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• University of Rochester: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 11389271 BACKGROUND

• 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.

  PMID: 12415044 BACKGROUND

Study Officials

• Erik S. Thingvoll, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erik S. Thingvoll, MD

CONTACT

585-275-1847; erik_thingvoll@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 13, 2007
• First Posted: August 15, 2007
• Study Start: July 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: May 30, 2008

Record last verified: 2007-08

Locations

US (1)