Topical Umbilical Cord Care for the Prevention of Colonization and Invasive Infections
Information source: University of Virginia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Line Insertion Site
Intervention: Povidone-Iodine (Drug); Chlorhexidine (Drug); Pluronic (Drug); Control (Other)
Phase: N/A
Status: Active, not recruiting
Sponsored by: University of Virginia Official(s) and/or principal investigator(s): David A Kaufman, MD, Principal Investigator, Affiliation: UVA School of Medicine
Summary
Umbilical catheters are necessary for many infants admitted to the Newborn Intensive Care
Unit (NICU)and utilized when indicated for up to 7 to 14 days. Bacterial colonization can
occur at the umbilical stump and potentially lead to serious bloodstream infections (BSIs).
This study is a prospective, randomized controlled feasibility trial to evaluate three types
of hygiene products on umbilical line stumps, on the effect of line colonization and
subsequent infections. Infants admitted to the NICU with an umbilical line(s) will be
randomized into one of four study groups, three products against standard of care (no
product). The three products that will be evaluated are currently being used in different
capacities for skin care in the UVA NICU. The study hypothesizes that daily topical
application of 1 or more antiseptic to the top of the umbilical stump will decrease
colonization of the umbilical stump while umbilical lines are in place.
Clinical Details
Official title: Topical Umbilical Cord Care for the Prevention of Colonization and Invasive Infections
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Colonization of umbilical stump
Secondary outcome: Late-onset infectioncontact dermatitis
Detailed description:
Umbilical catheter associated infections are higher (4. 4 vs. 3. 4 CLABSIs per 1000 line days)
than other central lines such as PICCs and surgically placed CVLin the NICU. (www. CDC. gov -
NSHN 2010 Report). Routine care of the skin entry site (e. g. central line dressing care) is
standard for other central lines, but there is no standard for care of the umbilical stump
while umbilical lines are in place.
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 once daily
product application.
Eligibility
Minimum age: N/A.
Maximum age: 7 Days.
Gender(s): Both.
Criteria:
Inclusion Criteria:
*≤7 days of life
*Umbilical line(s) in place (UAC and/or UVC)
Exclusion Criteria:
*Not meeting inclusion criteria
Locations and Contacts
Univeristy of Virginia Health System, Charlottesville, Virginia 22908, United States
Additional Information
Starting date: November 2012
Last updated: June 20, 2013
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