Pilot Study: Safety of Chlorhexidine (CHG) Baths in Patients Less Than 2 Months of Age
Condition: Chlorhexidine Allergy; Infection; Rash
Intervention: Chlorhexidine gluconate
Intervention description: Bi-weekly chlorhexidine baths
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 36 Weeks
Maximum age: 48 Weeks
Healthy volunteers: No
Keywords: chlorhexidine; safety; bath; rash; infant

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.
    

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.