drugset / Trial / NCT02326467

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

NCT02326467

Phase 1 Completed 10 enrolled Celeste Chandonnet
NaSingle-groupOpen-labelOther

Summary

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.

Timeline

Start
2016-02
Primary completion
2018-09-13
Completion
2019-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Chlorhexidine gluconate Other / unclassified 2 % Topical