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

Completed · Not applicable

Conditions studied: Colonization

In brief

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.

Key facts

Study ID

NCT01886001

Run by

University of Virginia

People needed

53

Starts

2012-11-01

Expected to finish

2013-07-01

Last updated by the study team

2018-05-03

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≤7 days of life
• Umbilical line(s) in place (UAC and/or UVC)

You may not qualify if…

• Not meeting inclusion criteria

Where it is running

• Univeristy of Virginia Health System — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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