Umbilical Cord Care for the Prevention of Colonization

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Line Insertion Site, Central Line-associated Bloodstream Infection (CLABSI)

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 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.

Key facts

Study ID

NCT01893060

Run by

University of Virginia

People needed

100

Starts

2013-07-01

Expected to finish

2014-07-01

Last updated by the study team

2013-08-02

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 (Umbilical arterial catheter=UAC and/or Umbilical venous catheter=UVC)

You may not qualify if…

• Not meeting inclusion criteria

Where it is running

• University of Virginia HealthSystem — Charlottesville, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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