Umbilical Cord Care for the Prevention of Colonization

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.

Study Overview

• Status: Unknown
• Conditions: Central Line-associated Bloodstream Infection (CLABSI); Line Insertion Site
• Intervention / Treatment: Drug: Povidone-Iodine; Drug: Chlorhexidine gluconate; Drug: Pluronic Cream; Other: control

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: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David A Kaufman, MD; Phone Number: 434-924-9114; Email: dak4r@virginia.edu
• Study Contact Backup: Name: Amy E Blackman, BSN; Phone Number: 434-982-0263; Email: as5v@virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22932
      • Recruiting
      • University of Virginia HealthSystem
      • Contact: Amy E. Blackman, MD; Phone Number: 434-982-0263; Email: as5v@virginia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 week (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: Sham control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Colonization of umbilical stump	While umbilical lines are in place, average of 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late-onset infection	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).	up to 120 days of life, transfer, death or discharge from NICU
Contact dermatitis of cord or skin base		while lines are in place, average of 7 days

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: David A Kaufman, MD, UVA School of Medicine

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): May 1, 2014
• Study Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: June 20, 2013
• First Submitted That Met QC Criteria: July 1, 2013
• First Posted (Estimate): July 8, 2013

Study Record Updates

• Last Update Posted (Estimate): August 2, 2013
• Last Update Submitted That Met QC Criteria: August 1, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Prematurity; Colonization; Neonatal Intensive Care Unit; Central line care; Umbilical line colonization; Newborn Intensive Care Unit
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Plasma Substitutes; Blood Substitutes; Chlorhexidine; Povidone-Iodine; Povidone; Chlorhexidine gluconate
• Other Study ID Numbers: 16859