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

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University of Virginia

Status

Completed

Conditions

Colonization

Treatments

Other: Control
Drug: Chlorhexidine
Drug: Pluronic
Drug: Povidone-Iodine

Study type

Interventional

Funder types

Other

Identifiers

NCT01886001
16396

Details and patient eligibility

About

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.

Full 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.

Enrollment

53 patients

Sex

All

Ages

Under 7 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

\*Not meeting inclusion criteria

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

53 participants in 4 patient groups

Povidone-Iodine (Betadine)
Experimental group
Description:
Umbilical stump care. Povidone-Iodine, USP, Swabstick Singles, applied once a day to cord stump while umbilical line(s) are in place
Treatment:
Drug: Povidone-Iodine
Chlorhexidine
Experimental group
Description:
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
Treatment:
Drug: Chlorhexidine
Pluronic
Experimental group
Description:
Umbilical stump care. Pluronic gel - (F68, Polymyxin, Nystatin, Nitrofurantoin )applied once a day to cord stump while umbilical line(s) are in place
Treatment:
Drug: Pluronic
Control (no application)
Sham Comparator group
Description:
Control arm, no product is applied, which is standard of care.
Treatment:
Other: Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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