Infection Associated With CatheterNCT01365312
Safety and Efficacy Study of Ethanol Locking to Prevent Central Line Infection in Premature Neonates
A study testing Ethanol lock and Heparinized saline in people with Infection Associated With Catheter and Bacteremia, run by East Carolina University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 32 weeks
- Conditions the study is for
- Infection Associated With Catheter, Bacteremia, Sepsis
- What is being tested?
- Ethanol lock and Heparinized saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants < 32 weeks gestation at birth who require a PICC
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina University
Greenville, North Carolina, 27834
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Infection Associated With Catheter, Bacteremia, Sepsis
- Being tested
- Ethanol lock, Heparinized saline
- Keywords
- Central line associated infection, PICC associated infection, Neonatal central line associated sepsis, Central line colonization, Ethanol Lock
- Medical subject headings
- Catheter-Related Infections, Bacteremia, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethanol lockDrug
Placement of 0.5 cc 70% ethanol, every 72 hours, for 15 minutes, into PICC lines randomized to ethanol intervention
Heparinized salineDrug
0.5 cc heparinized saline to be placed once every 72 hours for 15 minutes, in PICC lines randomized to placebo
| Study group | Role | What they receive |
|---|---|---|
| Ethanol | Experimental | Assigned intervention is a 70% ethanol lock, placed every 72 hours for 15 minutes, for the duration of the PICC line. Receives: 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. Receives: Drug: Heparinized saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Study Day #28 or sooner if PICC is discontinued before day #28
Secondary outcomes (6)
Evaluation of PICC colonization following ethanol locking
PICC colonization is reflected by growth of >15 CFU from a 5-cm segement of the PICC tip by semiquantitative (roll-plate) culture, or growoth of >100 CFU by quantitative (sonication) broth culture in an otherwise asymptomatic patient.
Measured: Duration of PICC use, average of 3 weeks
Whether the primary and secondary endpoints differ by birthweight strata
Birthweight stratification will use a 3-tiered subset (<1000g, 1000-1250g, and >1250g) consistent with existing neonatal literature.
Measured: Duration of PICC use, average of 3 weeks
To determine whether ethanol lock treatment impacts incidence of clinical evaluations for suspected sepsis
Other evaluations for suspected sepsis are those not defined by the primary endpoint but meeting criteria for infection of some other sterile body fluid (urine or CSF).
Measured: 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
See above
Measured: Duration of PICC use, average of 3 weeks
Determine side effects of ethanol locking in premature babies
To determine the side effects of flushing ethanol locks into premature infants following lock therapy, if any
Measured: Duration of PICC use, average of 3 weeks
To determine effect of ethanol locking on neonatal PICC lines
To determine how ethanol locking affects central line function and integrity in vivo, if at all.
Measured: Duration of PICC use, average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startFeb 2010
- Primary completionJun 2011
Why it stopped: Primary investigator relocated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection Associated With CatheterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amber Fort, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365312
- Sponsor's protocol ID
- NeonatalELT
- Status last verified
- Oct 2014
- First submitted
- 31 May 2011
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01365312
- Acronym / sponsor ID
- NeonatalELT
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary investigator relocated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jun 2011 (actual)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ethanol | Experimental | Drug: Ethanol lockAssigned intervention is a 70% ethanol lock, placed every 72 hours for 15 minutes, for the duration of the PICC line. |
| Heparinized saline | Placebo comparator | Drug: Heparinized salineIntervention is to place a heparinized saline lock every 72 hours for 15 minutes, for the duration of the line. |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infants < 32 weeks gestation at birth who require a PICC
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethanol lockPlacement of 0.5 cc 70% ethanol, every 72 hours, for 15 minutes, into PICC lines randomized to ethanol intervention | Drug | Ethanol |
| Heparinized saline0.5 cc heparinized saline to be placed once every 72 hours for 15 minutes, in PICC lines randomized to placebo | Drug | Heparinized saline |
Primary outcome
Incidence of PICC-related sepsis in infants with ethanol-treated vs. Placebo treated lines
Time frame: Study Day #28 or sooner if PICC is discontinued before day #28
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.
6 secondary outcomes
Evaluation of PICC colonization following ethanol locking
Time frame: Duration of PICC use, average of 3 weeks
Whether the primary and secondary endpoints differ by birthweight strata
Time frame: Duration of PICC use, average of 3 weeks
To determine whether ethanol lock treatment impacts incidence of clinical evaluations for suspected sepsis
Time frame: 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
Time frame: Duration of PICC use, average of 3 weeks
Determine side effects of ethanol locking in premature babies
Time frame: Duration of PICC use, average of 3 weeks
To determine effect of ethanol locking on neonatal PICC lines
Time frame: Duration of PICC use, average of 3 weeks
Results and safety
The study was stopped early (reason given: Primary investigator relocated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethanol lock and Heparinized saline in people with Infection Associated With Catheter and Bacteremia, run by East Carolina University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Primary investigator relocated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PICC-related sepsis in infants with ethanol-treated vs. Placebo treated lines (time frame: Study Day #28 or sooner if PICC is discontinued before day #28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2014; AzTrials last refreshed its copy on 6 Nov 2026.