Clinical trial NCT01893060: Umbilical Cord Care for the Prevention of Colonization
Official title: Umbilical Cord Care for the Prevention of Colonization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Line Insertion Site
Central Line-associated Bloodstream Infection (CLABSI)
Keywords: Prematurity
Central line care
Umbilical line colonization
Colonization
Newborn Intensive Care Unit
Neonatal Intensive Care Unit
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2013-07-08
Enrollment: 100
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Umbilical catheter associated infections are higher (4.4 vs. 3.4 CLABSIs per 1000 line days) than other central lines such as peripherally inserted central catheters (PICCs) and surgically placed central venous lines (CVL) in 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 twice daily product application.

Eligibility criteria: Inclusion Criteria:

\*≤7 days of life

\*Umbilical line(s) in place (Umbilical arterial catheter=UAC and/or Umbilical venous catheter=UVC)

Exclusion Criteria:

\*Not meeting inclusion criteria

Primary outcomes:
measure: Colonization of umbilical stump
timeFrame: While umbilical lines are in place, average of 7 days
Secondary outcomes:
measure: Late-onset infection
timeFrame: up to 120 days of life, transfer, death or discharge from NICU
measure: Contact dermatitis of cord or skin base
timeFrame: while lines are in place, average of 7 days
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia HealthSystem
state: Virginia
Study officials:
affiliation: UVA School of Medicine
name: David A Kaufman, MD
role: PRINCIPAL_INVESTIGATOR
References: