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NCT01365312 · ClinicalTrials.gov registry record · NA
Safety and Efficacy Study of Ethanol Locking to Prevent Central Line Infection in Premature Neonates
A NA study, sponsored by East Carolina University.
- Terminated
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT01365312 is a NA study that was terminated before completion, run by East Carolina University. The registered enrollment target is 10 participants.
The verdict
NCT01365312, a NA study, was terminated before completion, sponsored by East Carolina University.
- TERMINATED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
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 The solution is left for some period of time and is then either withdrawn from the line or flushed into the patient.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 hyp
Interventions
- DRUG Ethanol lock
- DRUG Heparinized saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2010-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01365312
The ClinicalTrials.gov registry entry for NCT01365312 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is East Carolina University, which has 58 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ethanol lock is the first listed.
NCT01365312 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01365312 about?
NCT01365312 is a clinical study titled "Safety and Efficacy Study of Ethanol Locking to Prevent Central Line Infection in Premature Neonates". 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 s...
What is the current status of trial NCT01365312?
This trial is currently terminated. It is a NA study. The enrollment target is 10 participants. The study started on 2010-02.
What interventions are being tested in trial NCT01365312?
The interventions under investigation include: Ethanol lock (DRUG), Heparinized saline (DRUG).
Who is sponsoring clinical trial NCT01365312?
This trial is sponsored by East Carolina University, which has 58 total clinical trials registered on ClinicalTrials.gov.
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