Recruiting

Umbilical Cord Care

Sponsor:

University of Virginia

Code:

NCT01893060

Conditions

Line Insertion Site

Central Line-associated Bloodstream Infection (CLABSI)

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Povidone-Iodine

Chlorhexidine gluconate

Pluronic Cream

control

Study Details

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.

Conditions

Line Insertion Site

Central Line-associated Bloodstream Infection (CLABSI)

Study ID

NCT01893060

Start date

Jul, 2013

Status verified date

Aug, 2013

Completion date

Jul, 2014

Anticipated

Primary completion date

May, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

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

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

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.

Interventions

Povidone-Iodine

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

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

Pluronic Cream

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.

Primary outcome measure

  • Colonization of umbilical stump [ Time Frame: While umbilical lines are in place, average of 7 days ]

Central Contacts and Locations

Central contacts

David A Kaufman, MD

434-924-9114dak4r@virginia.edu

Amy E Blackman, BSN

434-982-0263as5v@virginia.edu

Locations

University of Virginia HealthSystem

Recruiting

Charlottesville, Virginia, United States, 22932

Contacts

David A Kaufman, MD

434-924-5428dak4r@virginia.edu

Amy E. Blackman, MD

434-982-0263as5v@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Aug 2, 2013

Last verified

Aug, 2013

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2013-08-02.