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Safety and Efficacy Study of Ethanol Locking to Prevent Central Line Infection in Premature Neonates

NCT01365312 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-10-03

No results posted yet for this study

Summary

Appropriate delivery of adequate nutrition and medications in premature infants often requires central venous access in the form of a special IV called a PICC (peripherally inserted central catheter). While a necessary feature of neonatal intensive care, PICCs pose significant risk: among the most serious of these is infection. One common, successful infection control practice used in older children and adults involves the use of a lock, in which a fluid-filled syringe is attached to the end of an IV when it is not in use in order to prevent and/or treat clotting or infection. The solution is left for some period of time and is then either withdrawn from the line or flushed into the patient. The solution could be saline, antibiotics, other antiseptics, or any combination of these. However in the premature infant, use of antibiotics as a locking compound risks leaving behind organisms resistant to treatment; antiseptics can irritate vessels and cause breakage to sensitive premature skin; saline has neither sterilization nor anti-infective properties. By contrast, ethanol neutralizes or kills most bacteria, viruses, and fungi without the risk of resistance, and because it is not externally applied there is no risk to baby skin. Ethanol-based lock protocols have been used safely and effectively in both adult and pediatric populations without adverse effects, but this has not been tested in premature babies because fluids and medication are delivered continuously: placement of a lock traditionally requires an extended pause (hours or days) in fluid and medication administration.

To overcome these key limitations, a periodic, brief ethanol lock protocol was designed such that both infant exposure and interruptions to fluid and medication delivery would be minimized. The lock is practical, cheap, easy to place, and takes advantage of an existing daily pause during which IV tubing and fluids hooked up to the PICC are changed. The objective of this study is to test the hypothesis that use of a 70% ethanol lock, every 3rd day, for 15 minutes, will safely and effectively reduce PICC infection in our unit.

Conditions

  • Infection Associated With Catheter
  • Bacteremia
  • Sepsis

Interventions

DRUG

Ethanol lock

Placement of 0.5 cc 70% ethanol, every 72 hours, for 15 minutes, into PICC lines randomized to ethanol intervention

DRUG

Heparinized saline

0.5 cc heparinized saline to be placed once every 72 hours for 15 minutes, in PICC lines randomized to placebo

Sponsors & Collaborators

  • East Carolina University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01365312 on ClinicalTrials.gov