drugset / Trial / NCT01886001

Topical Umbilical Cord Care for the Prevention of Colonization and Invasive Infections

NCT01886001

Completed 53 enrolled University of Virginia
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2012-11
Primary completion
2013-05
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Chlorhexidine Small molecule 2 % Topical
Subject Pluronic Unknown Topical
Subject Povidone-Iodine Other / unclassified Topical

Indications

No indication recorded.