Safety and Efficacy Study of Ethanol Locking to Prevent Central Line Infection in Premature Neonates
Status:
Terminated
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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and is then either withdrawn from the line or flushed into the patient.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.