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

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..

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.