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Umbilical Cord Care for the Prevention of Colonization

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ClinicalTrials.gov Identifier: NCT01893060
Recruitment Status : Unknown
Verified August 2013 by David A Kaufman, University of Virginia.
Recruitment status was:  Recruiting
First Posted : July 8, 2013
Last Update Posted : August 2, 2013
Sponsor:
Information provided by (Responsible Party):
David A Kaufman, University of Virginia

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.

Condition or disease Intervention/treatment Phase
Line Insertion Site Central Line-associated Bloodstream Infection (CLABSI) Drug: Povidone-Iodine Drug: Chlorhexidine gluconate Drug: Pluronic Cream Other: control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Umbilical Cord Care for the Prevention of Colonization
Study Start Date : July 2013
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Povidone-Iodine
Umbilical stump care. Povidone-Iodine, USP, Swabstick Singles, applied twice a day to cord stump while umbilical line(s) are in place
Drug: Povidone-Iodine
Povidone-Iodine, USP, Swabstick Singles, applied twice a day to cord stump while umbilical line(s) are in place
Other Name: Betadine

Experimental: 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
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
Other Name: ChloraPrep®

Experimental: 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
Drug: Pluronic Cream
Pluronic cream - (F68, Polymyxin, Nystatin, Nitrofurantoin )applied twice a day to cord stump while umbilical line(s) are in place
Other Names:
  • Pluronic Gel
  • Pluronic

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




Primary Outcome Measures :
  1. Colonization of umbilical stump [ Time Frame: While umbilical lines are in place, average of 7 days ]

Secondary Outcome Measures :
  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 of cord or skin base [ Time Frame: while lines are in place, average of 7 days ]


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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893060


Contacts
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Contact: David A Kaufman, MD 434-924-9114 dak4r@virginia.edu
Contact: Amy E Blackman, BSN 434-982-0263 as5v@virginia.edu

Locations
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United States, Virginia
University of Virginia HealthSystem Recruiting
Charlottesville, Virginia, United States, 22932
Contact: David A Kaufman, MD    434-924-5428    dak4r@virginia.edu   
Contact: Amy E. Blackman, MD    434-982-0263    as5v@virginia.edu   
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: David A Kaufman, MD UVA School of Medicine

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Responsible Party: David A Kaufman, Medical Doctor, University of Virginia
ClinicalTrials.gov Identifier: NCT01893060    
Other Study ID Numbers: 16859
First Posted: July 8, 2013    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: August 2013
Keywords provided by David A Kaufman, University of Virginia:
Prematurity
Central line care
Umbilical line colonization
Colonization
Newborn Intensive Care Unit
Neonatal Intensive Care Unit
Additional relevant MeSH terms:
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Iodine
Chlorhexidine
Chlorhexidine gluconate
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes