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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

Tracking Information
First Submitted Date  ICMJE June 20, 2013
First Posted Date  ICMJE July 8, 2013
Last Update Posted Date August 2, 2013
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2013)
Colonization of umbilical stump [ Time Frame: While umbilical lines are in place, average of 7 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2013)
  • 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).
  • Contact dermatitis of cord or skin base [ Time Frame: while lines are in place, average of 7 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Umbilical Cord Care for the Prevention of Colonization
Official Title  ICMJE Umbilical Cord Care for the Prevention of Colonization
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Line Insertion Site
  • Central Line-associated Bloodstream Infection (CLABSI)
Intervention  ICMJE
  • 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
  • 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®
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: Povidone-Iodine
  • 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
    Intervention: Drug: Chlorhexidine gluconate
  • 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
    Intervention: Drug: Pluronic Cream
  • 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.
    Intervention: Other: control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 1, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2014
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 7 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01893060
Other Study ID Numbers  ICMJE 16859
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David A Kaufman, University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David A Kaufman, MD UVA School of Medicine
PRS Account University of Virginia
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP