Pilot Study: Safety of Chlorhexidine (CHG) Baths in Patients Less Than 2 Months of Age
Condition: Chlorhexidine Allergy; Infection; Rash
Study type: Interventional
Phase: Phase 1

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..
    

Intervention name(s): Chlorhexidine gluconate
Intervention type(s): Drug
Intervention description(s): Bi-weekly chlorhexidine baths
Other intervention name(s): Sage® 2% Chlorhexidine Gluconate Cloth
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: chlorhexidine; safety; bath; rash; infant