Study of Chlorhexidine as the Hub Antiseptic to Prevent Catheter Related Infections in Newborn Infants

Catheter-related bloodstream infections (CRBSIs) are a major cause of morbidity and
mortality in infants admitted to the NICU. In adults, chlorhexidine used as a skin
antiseptic has been shown to reduce the incidence of CRBSIs, and recent evidence indicates
the inner surface of long-term central catheters as the likely route of infection. This
study will evaluate 3.15% chlorhexidine as the daily catheter hub antiseptic to reduce
catheter tip microbial colonization, an indication of high risk for acquiring CRBSI. The
purpose of this study is to compare the antiseptic capability of 3.15% chlorhexidine versus
isopropyl alcohol in reducing central catheter-related infections in neonates. This study
also aims to compare the time to catheter hub microbial colonization in the two groups and
to determine the route of catheter tip colonization by comparing cultures taken from the
catheter tip, hub, and skin insertion site.

This study will last 1 year. There are no study visits. The placement and removal of the
catheter will be determined by the discretion of the attendant caring for the participant.
Participants will be randomly assigned to one of two groups. Catheters of Group 1
participants will be treated with 3.15% chlorhexidine at the time of the daily intravenous
tubing change. Catheters of Group 2 participants will be treated with isopropyl alcohol. For
both groups, cultures of the inner surface of the catheter hub will be performed twice a
week, and cultures of the inner surface of the catheter hub, tip, and skin insertion site
will be performed upon removal of the catheter.

Inclusion Criteria:

- Admitted to the NICU

- Umbilical vein catheter or peripherally inserted central venous catheter (PICC)
anticipated to be in place for more than 48 hours

- Parent or guardian able to give informed consent prior to first hyperalimentation and
total parenteral nutrition tubing change

Exclusion Criteria:

- Known CRBSI-positive blood culture at the time of catheter line placement.

- Not expected to survive for more than 48 hours

- Broviac or any other surgically-placed central catheters

- Any condition that, as determined by the investigator, would interfere with
evaluation of the line or be a potential health risk to the participant