Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2013-07-31
2014-07-31
Brief Summary
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Detailed Description
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In a pilot study to evaluate the relationship of umbilical stump colonization with gestational age, the number of days the catheter was in place, and the type of organisms, colonization was detected in 78% of patients. There was a direct correlation with colonization and line days as well as an inverse relationship with lower gestational age.
This pilot data supported the need for the study of interventions to reduce umbilical stump colonization, which may help decrease blood stream infections (BSIs) associated with umbilical lines in the NICU. The proposed study will evaluate feasibility of twice daily product application.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Povidone-Iodine
Umbilical stump care. Povidone-Iodine, USP, Swabstick Singles, applied twice a day to cord stump while umbilical line(s) are in place
Povidone-Iodine
Povidone-Iodine, USP, Swabstick Singles, applied twice a day to cord stump while umbilical line(s) are in place
Chlorhexidine
Umbilical stump care. ChloraPrep® Chlorhexidine Gluconate 2% w/v; 70% Isopropyl Alcohol v/v Swabstick Single, applied twice a day to cord stump while umbilical line(s) are in place
Chlorhexidine gluconate
Chlorhexidine Gluconate 2% w/v; 70% Isopropyl Alcohol v/v Swabstick Single, applied twice a day to cord stump while umbilical line(s) are in place
Pluronic Cream
Umbilical stump care. Pluronic gel - (F68, Polymyxin, Nystatin, Nitrofurantoin), applied twice a day to cord stump while umbilical line(s) are in place
Pluronic Cream
Pluronic cream - (F68, Polymyxin, Nystatin, Nitrofurantoin )applied twice a day to cord stump while umbilical line(s) are in place
Control
No product is applied to cord stump while umbilical line(s) are in place. This is the current standard of care at UVA.
control
No product is applied to cord stump while umbilical line(s) are in place. This is the current standard of care at UVA.
Interventions
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Povidone-Iodine
Povidone-Iodine, USP, Swabstick Singles, applied twice a day to cord stump while umbilical line(s) are in place
Chlorhexidine gluconate
Chlorhexidine Gluconate 2% w/v; 70% Isopropyl Alcohol v/v Swabstick Single, applied twice a day to cord stump while umbilical line(s) are in place
Pluronic Cream
Pluronic cream - (F68, Polymyxin, Nystatin, Nitrofurantoin )applied twice a day to cord stump while umbilical line(s) are in place
control
No product is applied to cord stump while umbilical line(s) are in place. This is the current standard of care at UVA.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
\*Umbilical line(s) in place (Umbilical arterial catheter=UAC and/or Umbilical venous catheter=UVC)
7 Days
ALL
No
Sponsors
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University of Virginia
OTHER
Responsible Party
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David A Kaufman
Medical Doctor
Principal Investigators
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David A Kaufman, MD
Role: PRINCIPAL_INVESTIGATOR
UVA School of Medicine
Locations
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University of Virginia HealthSystem
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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16859
Identifier Type: -
Identifier Source: org_study_id
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