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

NCT01365312 | Terminated DMC

• 1 other identifier: NeonatalELT
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 The solution is left for some period of time and is then either withdrawn from the line or flushed into the patient.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

Keywords

Central line associated infection; PICC associated infection; Neonatal central line associated sepsis; Central line colonization; Ethanol Lock

Outcome Measures

Primary Outcomes (1)

• Incidence of PICC-related sepsis in infants with ethanol-treated vs. Placebo treated lines

  Primary endpoint of the study is to compare the incidence of PICC-related sepsis in infants with ethanol treated vs. Placebo treated lines by study day 28. PICC-related sepsis is defined by any 2 clinical signs or symptoms plus one positive peripheral blood culture for a recognized pathogen in this population other than coagulase-negative staphylococcus, or 2 positive peripheral blood cultures for coagulase-negative staphylococcus within 48 hours.

  Study Day #28 or sooner if PICC is discontinued before day #28

Secondary Outcomes (6)

• Evaluation of PICC colonization following ethanol locking

  Duration of PICC use, average of 3 weeks

• Whether the primary and secondary endpoints differ by birthweight strata

  Duration of PICC use, average of 3 weeks

• To determine whether ethanol lock treatment impacts incidence of clinical evaluations for suspected sepsis

  Duration of PICC use, average of 3 weeks

• To determine whether antibiotic use for any indication (including non-bacteremia) alters the incidence of PICC-related infection or colonization as defined in the primary and secondary endpoints

  Duration of PICC use, average of 3 weeks

• Determine side effects of ethanol locking in premature babies

  Duration of PICC use, average of 3 weeks

Study Arms (2)

Ethanol

EXPERIMENTAL

Assigned intervention is a 70% ethanol lock, placed every 72 hours for 15 minutes, for the duration of the PICC line.

Drug: Ethanol lock

Heparinized saline

PLACEBO COMPARATOR

Intervention is to place a heparinized saline lock every 72 hours for 15 minutes, for the duration of the line.

Drug: Heparinized saline

Interventions

Ethanol lock DRUG

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

Ethanol

Heparinized saline DRUG

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

Heparinized saline

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants \< 32 weeks gestation at birth who require a PICC

You may not qualify if:

• 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

Sponsors & Collaborators

• East Carolina University: lead

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27834, United States

Location

MeSH Terms

Conditions

Catheter-Related Infections; Bacteremia; Sepsis

Condition Hierarchy (Ancestors)

Infections; Bacterial Infections; Bacterial Infections and Mycoses; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Amber Fort, DO, MPH, MS

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 3, 2011
• Study Start: February 1, 2010
• Primary Completion: June 1, 2011
• Last Updated: October 3, 2014

Record last verified: 2014-10

Locations

US (1)