Umbilical Cord Care for the Prevention of Colonization

University of Virginia

Status: Unknown

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

Treatments: Drug: Pluronic Cream; Drug: Povidone-Iodine; Drug: Chlorhexidine gluconate; Other: control

Study type: Interventional

Funder types: Other

Identifiers

NCT01893060

16859

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 7 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Povidone-Iodine

Experimental group

Description:

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

Treatment:

Drug: Povidone-Iodine

Chlorhexidine

Experimental group

Description:

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

Treatment:

Drug: Chlorhexidine gluconate

Pluronic Cream

Experimental group

Description:

Umbilical stump care. Pluronic gel - (F68, Polymyxin, Nystatin, Nitrofurantoin), applied twice a day to cord stump while umbilical line(s) are in place

Treatment:

Drug: Pluronic Cream

Control

Sham Comparator group

Description:

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

Treatment:

Other: control