Safety and Efficacy Study of Ethanol Locking to Prevent Central Line Infection in Premature Neonates
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, Hospital, Hematology |
| Therapuetic Areas: | Hematology, Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/8/2014 |
| Start Date: | February 2010 |
| Contact: | Amber E Fort, DO |
| Email: | forta@ecu.edu |
| Phone: | 252-847-9571 |
A Prospective, Randomized, Blinded, Placebo-Controlled Trial of Periodic, Brief Ethanol Locks to Prevent Peripherally-Inserted Central Catheter (PICC) Infections in Preterm Infants in the Neonatal Intensive Care Unit
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and is then either withdrawn from the line or flushed into the patient.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.
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.
PICC infection is of particular concern in the NICU because of the need for long term
intravenous access in many very-low and the majority of extremely-low birthweight infants,
the very populations at highest risk for infection in the first place. Central lines are a
mainstay of treatment in these babies because of the need for extended parenteral nutrition,
which itself has been associated with blood stream infection, not to mention the increased
use of anti-infectives, added hospitalization costs, longer length of stay, and negative
impact upon nutrition delivery when infectious complications occur.
Existing infection control practices differ by unit and region, and include hand washing,
sterile precautions at insertion and dressing changes, elimination of mandatory scheduled
dressing changes, minimizing port access to the extent permitted by clinical care,
prophylactic antibiotics, and closed medication systems. Success is variable: there is no
standard highly effective, safe approach to infection control, and central line infection
remains a leading cause of morbidity and mortality in the NICU.
A standard practice to maintain central line patency when it is not in use is to lock it
with a syringe containing a heparinized solution. Locks containing antibiotics have been
used to prevent infection of central lines and to treat already-infected lines, but this
approach confers risk of development of organisms resistant to treatment. External
chlorhexidine-impregnated dressings have been used but can harm premature skin and do not
achieve sterilization of the lumen or hub, where most infections originate.
Medical grade ethyl alcohol (ethanol) is a widely used compound with uses as a disinfectant,
preservative, antidote to ingested ethylene glycol (anti-freeze), and anti-microbial. The
FDA lists no specific approval or indication though it's use is widely recognized. Multiple
studies have been conducted in sheep, children and adults, using 0.5-2 mL 70% ethanol locks
to successfully prevent and/or treat catheter related infection without development of
resistant organisms, adverse side effects to patients, or disruptions in catheter integrity.
Though the ethanol lock approach has not yet been applied to premature neonates, safe and
successful precedent in humans as young as 3 months is established; ours is the first trial
of ethanol locking in a NICU setting.
intravenous access in many very-low and the majority of extremely-low birthweight infants,
the very populations at highest risk for infection in the first place. Central lines are a
mainstay of treatment in these babies because of the need for extended parenteral nutrition,
which itself has been associated with blood stream infection, not to mention the increased
use of anti-infectives, added hospitalization costs, longer length of stay, and negative
impact upon nutrition delivery when infectious complications occur.
Existing infection control practices differ by unit and region, and include hand washing,
sterile precautions at insertion and dressing changes, elimination of mandatory scheduled
dressing changes, minimizing port access to the extent permitted by clinical care,
prophylactic antibiotics, and closed medication systems. Success is variable: there is no
standard highly effective, safe approach to infection control, and central line infection
remains a leading cause of morbidity and mortality in the NICU.
A standard practice to maintain central line patency when it is not in use is to lock it
with a syringe containing a heparinized solution. Locks containing antibiotics have been
used to prevent infection of central lines and to treat already-infected lines, but this
approach confers risk of development of organisms resistant to treatment. External
chlorhexidine-impregnated dressings have been used but can harm premature skin and do not
achieve sterilization of the lumen or hub, where most infections originate.
Medical grade ethyl alcohol (ethanol) is a widely used compound with uses as a disinfectant,
preservative, antidote to ingested ethylene glycol (anti-freeze), and anti-microbial. The
FDA lists no specific approval or indication though it's use is widely recognized. Multiple
studies have been conducted in sheep, children and adults, using 0.5-2 mL 70% ethanol locks
to successfully prevent and/or treat catheter related infection without development of
resistant organisms, adverse side effects to patients, or disruptions in catheter integrity.
Though the ethanol lock approach has not yet been applied to premature neonates, safe and
successful precedent in humans as young as 3 months is established; ours is the first trial
of ethanol locking in a NICU setting.
Inclusion Criteria:
- Preterm infants < 32 weeks gestation at birth who require a PICC
Exclusion Criteria:
- Any baby with a positive blood culture less than 48 hours prior to PICC placement;
any infant who requires pressors in excess of >5 mcg/kg/min
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