Overview

This trial is active, not recruiting.

Condition line insertion site
Treatments povidone-iodine, chlorhexidine, pluronic, control
Sponsor University of Virginia
Start date November 2012
End date May 2013
Trial size 100 participants
Trial identifier NCT01886001, 16396

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Umbilical stump care. Povidone-Iodine, USP, Swabstick Singles, applied once a day to cord stump while umbilical line(s) are in place
povidone-iodine Betadine
Umbilical stump care. Povidone-Iodine, USP, Swabstick Singles, applied once a day to cord stump while umbilical line(s) are in place
(Experimental)
Umbilical stump care. ChloraPrep® Chlorhexidine Gluconate 2% w/v; 70% Isopropyl Alcohol v/v Swabstick Single, applied once a day to cord stump while umbilical line(s) are in place
chlorhexidine ChloraPrep®
Umbilical stump care. Chlorhexidine Gluconate 2% w/v; 70% Isopropyl Alcohol v/v Swabstick Single, applied once a day to cord stump while umbilical line(s) are in place
(Experimental)
Umbilical stump care. Pluronic gel - (F68, Polymyxin, Nystatin, Nitrofurantoin )applied once a day to cord stump while umbilical line(s) are in place
pluronic Pluronic Gel
Umbilical stump care. Pluronic gel - (F68, Polymyxin, Nystatin, Nitrofurantoin)applied once a day to cord stump while umbilical line(s) are in place
(Sham Comparator)
control
No product is applied to cord stump while umbilical line(s) are in place. This is the current standard of care at UVA.

Primary Outcomes

Measure
Colonization of umbilical stump
time frame: while umbilical lines are in place which is an average of 7 days

Secondary Outcomes

Measure
Late-onset infection
time frame: up to 120 days of life, transfer, death or discharge from NICU
contact dermatitis
time frame: during intervention which is an average of 7 days

Eligibility Criteria

Male or female participants up to 7 days old.

Inclusion Criteria: *≤7 days of life *Umbilical line(s) in place (UAC and/or UVC) Exclusion Criteria: *Not meeting inclusion criteria

Additional Information

Official title Topical Umbilical Cord Care for the Prevention of Colonization and Invasive Infections
Principal investigator David A Kaufman, MD
Description Umbilical catheter associated infections are higher (4.4 vs. 3.4 CLABSIs per 1000 line days) than other central lines such as PICCs and surgically placed CVLin 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 once daily product application.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by University of Virginia.