Safety of Biweekly Chlorhexidine Gluconate Bathing in Infants 36 To 48 Weeks' Postmenstrual Age.

BACKGROUND: Little evidence supports use of chlorhexidine gluconate (CHG) baths to reduce health care-associated infections, including central catheter-associated bloodstream infections in infants less than 2 months old.

OBJECTIVE: To describe the safety of biweekly CHG baths in infants less than 2 months old by measuring blood levels of CHG, liver and renal function, skin reactions, and adverse events.

METHODS: Study participants received twice-weekly 2% CHG baths, weekly blood tests, and twice-daily skin assessments. Adverse events were monitored.

RESULTS: Ten infants 36 to 48 weeks' postmenstrual age with central venous catheters admitted to the neonatal or cardiac intensive care unit were enrolled before the study was closed by the Food and Drug Administration. The 9 patients contributing data had 83 CHG exposures; 31 CHG levels were analyzed. All patients had evidence of CHG absorption. Seven patients had CHG levels of 100 ng/mL or greater. Findings did not support accumulation of CHG but did show evidence of higher absorption than previously reported. Results of liver and renal function studies remained within reference limits. No patient had any adverse events, including skin reactions.

CONCLUSIONS: Although no adverse events were observed, our patients had evidence of CHG absorption. The effects of this absorption remain unknown. More research is needed to determine safe blood levels of CHG in infants less than 2 months of age.