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Umbilical Cord Care for the Prevention of Colonization

NCT ID: NCT01893060

Last Updated: 2013-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-07-31

Brief Summary

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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

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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.

Conditions

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Line Insertion Site Central Line-associated Bloodstream Infection (CLABSI)

Keywords

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Prematurity Central line care Umbilical line colonization Colonization Newborn Intensive Care Unit Neonatal Intensive Care Unit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Povidone-Iodine

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

Group Type EXPERIMENTAL

Povidone-Iodine

Intervention Type DRUG

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

Chlorhexidine

Umbilical stump care. ChloraPrep® Chlorhexidine Gluconate 2% w/v; 70% Isopropyl Alcohol v/v Swabstick Single, applied twice a day to cord stump while umbilical line(s) are in place

Group Type EXPERIMENTAL

Chlorhexidine gluconate

Intervention Type DRUG

Chlorhexidine Gluconate 2% w/v; 70% Isopropyl Alcohol v/v Swabstick Single, applied twice a day to cord stump while umbilical line(s) are in place

Pluronic Cream

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

Group Type EXPERIMENTAL

Pluronic Cream

Intervention Type DRUG

Pluronic cream - (F68, Polymyxin, Nystatin, Nitrofurantoin )applied twice a day to cord stump while umbilical line(s) are in place

Control

No product is applied to cord stump while umbilical line(s) are in place. This is the current standard of care at UVA.

Group Type SHAM_COMPARATOR

control

Intervention Type OTHER

No product is applied to cord stump while umbilical line(s) are in place. This is the current standard of care at UVA.

Interventions

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Povidone-Iodine

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

Intervention Type DRUG

Chlorhexidine gluconate

Chlorhexidine Gluconate 2% w/v; 70% Isopropyl Alcohol v/v Swabstick Single, applied twice a day to cord stump while umbilical line(s) are in place

Intervention Type DRUG

Pluronic Cream

Pluronic cream - (F68, Polymyxin, Nystatin, Nitrofurantoin )applied twice a day to cord stump while umbilical line(s) are in place

Intervention Type DRUG

control

No product is applied to cord stump while umbilical line(s) are in place. This is the current standard of care at UVA.

Intervention Type OTHER

Other Intervention Names

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Betadine ChloraPrep® Pluronic Gel Pluronic Sham control

Eligibility Criteria

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Inclusion Criteria

\*≤7 days of life

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

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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David A Kaufman

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David A Kaufman, MD

Role: PRINCIPAL_INVESTIGATOR

UVA School of Medicine

Locations

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University of Virginia HealthSystem

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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David A Kaufman, MD

Role: CONTACT

Phone: 434-924-9114

Email: [email protected]

Amy E Blackman, BSN

Role: CONTACT

Phone: 434-982-0263

Email: [email protected]

Facility Contacts

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David A Kaufman, MD

Role: primary

Amy E. Blackman, MD

Role: backup

Other Identifiers

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16859

Identifier Type: -

Identifier Source: org_study_id