CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 10 enrolled
Drug / intervention
Chlorhexidine gluconatedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02326467
NCT02326467Phase 1Completed

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

Celeste Chandonnet·interventional·Posted Dec 29, 2014·Updated Jul 27, 2021

In Brief

A Phase 1 clinical trial evaluating Chlorhexidine gluconate for Chlorhexidine Allergy and 2 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 29, 2014
Enrollment StartFeb 1, 2016
Primary CompletionSep 13, 2018
Study CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 11.5 years ago

Interventions

Chlorhexidine gluconatedrug

Bi-weekly chlorhexidine baths