Pilot Study: Safety of Chlorhexidine (CHG) Baths in Patients Less Than 2 Months of Age

Completed · Phase 1

Conditions studied: Chlorhexidine Allergy, Infection, Rash

In brief

Literature provides overwhelming evidence supporting the use of chlorhexidine gluconate (CHG) a rapid onset, broad spectrum, topical antiseptic for reducing healthcare-associated infections (HAIs). CHG is believed to be superior to other forms of antiseptics because, when it is applied to the skin surface, it leaves a lasting residue on the skin. CHG has been shown to be well tolerated in patients 2 months of age and older. However there is limited evidence to support the use of topically applied CHG in infants less than 2 months of age because of potential safety concerns in this population. The purpose of this study will be to describe the safety of bi-weekly CHG baths in a sample of Newborn Intensive Care Unit (NICU) and pediatric Cardiac Intensive Care Unit (CICU) patients by measuring the incidence of skin problems and CHG blood levels.

Key facts

Study ID
NCT02326467
Run by
Celeste Chandonnet
People needed
10
Starts
2016-02-01
Expected to finish
2019-07-01
Last updated by the study team
2021-07-27

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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