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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
Evidence overwhelmingly supports the use of Chlorhexidine Gluconate (CHG) a rapid onset, broad spectrum, topical antiseptic for reducing Healthcare-associated Infections (HAIs). CHG provides prolonged protection against both gram-positive and gram-negative organisms. Reports indicate CHG is well tolerated in patients greater than two months of age. However, due to safety concerns, there is limited evidence to support the use of topically applied CHG in infants less than 2 months of age. The purpose of this Phase I Clinical (pilot) study is to describe the safety of bi-weekly CHG baths in a sample of 50 Newborn Intensive Care Unit (NICU) and pediatric Cardiac Intensive Care Unit (CICU) patients, (36 weeks PMA or older, less than 2 months of age or 48 weeks PMA and with a CVC), by measuring the incidence of skin problems and CHG blood levels. CHG baths will be performed every Monday and Thursday during the day shift, for up to 12 weeks post enrollment or until the CVC is removed or the patient is discharged. Chlorhexidine Gluconate bathing cloths are marketed for peri-operative skin preparation. However, daily CHG baths are a common practice in ICUs around the nation because of its proven method for preventing HAIs in patients > 2 months of age and older. Furthermore, CHG use for skin antisepsis has become a widely accepted practice, and it is now part of the Centers for Disease Control and Prevention (CDC) CVC maintenance bundle for use in patients greater than 2 months of age, and a recommendation to use with caution in infants < 2 months of age. Hypothesis 1:CHG will be safe for use in a sample of infants 36 weeks PMA or older, and less than 2 months of age (48 weeks PMA) with a CVC as evidenced by an adverse event rate less than 10%. Hypothesis 2: Twice weekly CHG baths do not lead to rising (cumulative) CHG blood levels, LFTs (AST/ALT) and Serum Creatinine over time in a sample of infants 36 weeks PMA or older, and less than 2 months of age (48 weeks PMA) with a CVC..

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

Conditions
-----------------
Chlorhexidine Allergy, Infection, Rash

Intervention / Treatment
-----------------
* Drug: Chlorhexidine gluconate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria. Greater than/equal to 36 weeks PMA (gestational age + chronological age) Less than/equal to 48 weeks PMA (gestational age + chronological age) Greater than/equal to 3 days of age Existing or soon to be placed, peripheral or surgical CVC Permission to participate in trial by attending physician Parent or legal guardian informed consent to participate in the trial Exclusion criteria. • Infant with a large open lesion or severe skin condition (i.e., Myelomeningocele, Gastroschisis, lymphatic malformation, open chest, ostomies and/or mucus fistulas or Icthyosis) Infants with active seizure disorders Infants with Hypoxic Ischemic Encephalopathy Infants with severe multi-system organ failure or Liver failure as defined by documentation of abnormal liver function tests: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) Gamma-glutamyltransferase (GGT) and L-lactate dehydrogenase (LD). Infant with renal impairment as defined by: documented serum Creatinine greater than 0.7, renal disorders (renal agenesis, polycystic kidney disease, dysplastic kidneys, acute renal injury). Infants deemed clinically unstable by their physician such as patients that are extremely fragile and wouldn't tolerate the stimulation of the bathing process or those infants being considered for withdrawal of care.

Ages Eligible for Study
-----------------
Minimum Age: 36 Weeks
Maximum Age: 48 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine gluconate bath<br>All subjects will receive a bath twice a week with 2% CHG bathing cloths. The baths will be followed by blood sampling for CHG levels prior to initiation of baths and every Friday for the duration of study participation. The study team will monitor the infant's skin for evidence of untoward lesions prior to the first bath and every 12 hours during the course of the study. CHG blood levels will be monitored for associated adverse events and accumulation. | Drug: Chlorhexidine gluconate<br>* Bi-weekly chlorhexidine baths<br>* Other names: Sage® 2% Chlorhexidine Gluconate Cloth;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Study Participants With Skin Reactions Less Than 10% | Study RN's will perform a full body skin assessment for skin irritation or open areas prior to each bath. Bedside RN's will complete skin assessments every 12 hours during the course of the study. Descriptive statistics including mean, median, range and frequencies will be used to describe adverse events (including skin reactions and other untoward events). We will characterize the demographic and clinical characteristics of subjects that experience adverse events, although we will not perform hypothesis tests of association. We will consider time-to-rash data using Kaplan-Meier estimators. | Adverse Events assessed every 12 hours for the duration of study participation (max 90 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants With Detectable CHG Blood Levels | To monitor for absorption into the blood, a single CHG level will be obtained at baseline and then weekly on Fridays for the remainder of the study for each study participant. A CHG level will also be drawn when an infant is removed from the study in response to an adverse reaction. Of note, a threshold for safe, normal or toxic CHG level is not known, thus we will closely monitor blood levels and convene a meeting of the Data Safety and Monitoring Committee (DSMC) if adverse reactions develop in association with elevated blood levels. | CHG blood levels will be assessed at baseline, then weekly for the duration of study participation (max 90 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infant, chlorhexidine, safety, bath, rash