drugset / Trial / NCT01893060

Umbilical Cord Care for the Prevention of Colonization

NCT01893060

Unknown 100 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 University of Virginia (UVA) NICU. The study hypothesizes that twice 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
2013-07
Primary completion
2014-05
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Chlorhexidine gluconate Other / unclassified Topical
Subject Pluronic Cream Unknown Topical
Subject Povidone-Iodine Other / unclassified Topical

Indications

No indication recorded.