Umbilical Cord Care for the Prevention of Colonization

Study Overview
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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.

Official Title
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Umbilical Cord Care for the Prevention of Colonization

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

Intervention / Treatment
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* Drug: Povidone-Iodine
* Drug: Chlorhexidine gluconate
* Drug: Pluronic Cream
* Other: control


Participation Criteria
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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) Exclusion Criteria: *Not meeting inclusion criteria

Ages Eligible for Study
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Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Povidone-Iodine<br>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<br>* Povidone-Iodine, USP, Swabstick Singles, applied twice a day to cord stump while umbilical line(s) are in place<br>* Other names: Betadine;|
| Experimental: Chlorhexidine<br>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<br>* 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<br>* Other names: ChloraPrep®;|
| Experimental: Pluronic Cream<br>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<br>* Pluronic cream - (F68, Polymyxin, Nystatin, Nitrofurantoin )applied twice a day to cord stump while umbilical line(s) are in place<br>* Other names: Pluronic;|
| Sham Comparator: Control<br>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<br>* No product is applied to cord stump while umbilical line(s) are in place. This is the current standard of care at UVA.<br>* Other names: Sham control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prematurity, Central line care, Umbilical line colonization, Colonization, Newborn Intensive Care Unit, Neonatal Intensive Care Unit