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Completed

NCT Number: NCT01886001

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

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.

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Key information

Conditions

Colonization

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy of Virginia Health System

Charlottesville, Virginia, 22908, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

*≤7 days of life

*Umbilical line(s) in place (UAC and/or UVC)

Exclusion criteria

*Not meeting inclusion criteria

Treatment and study plan

Povidone-Iodine

Drug

Umbilical stump care. Povidone-Iodine, USP, Swabstick Singles, applied once a day to cord stump while umbilical line(s) are in place

Other names: Betadine

Chlorhexidine

Drug

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

Other names: ChloraPrep®, Chlorhexidine Gluconate 2% w/v;70% Isopropyl Alcohol

Pluronic

Drug

Umbilical stump care. Pluronic gel - (F68, Polymyxin, Nystatin, Nitrofurantoin)applied once a day to cord stump while umbilical line(s) are in place

Other names: Pluronic Gel

Control

Other

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

  1. Colonization of umbilical stump

    Time frame: while umbilical lines are in place which is an average of 7 days

Secondary outcomes

  1. Late-onset infection

    Time frame: up to 120 days of life, transfer, death or discharge from NICU

    Late-onset infections include BSI, urinary tract infection (UTI), and meningitis. Catheter associated blood stream infections (CLABSI) for this study will be defined as growth in 1 or more blood cultures of any organism including CONS during or within 48-72 hours of having a central line in place, with signs and symptoms of sepsis, and treated for 7 days. Additionally we will compare the CDC definition of CLABSI between groups, and length of stay (LOS).

  2. contact dermatitis

    Time frame: during intervention which is an average of 7 days

    Skin irritation around the umbilical stump

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 25, 2013
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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