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

Condition(s) targeted: Chlorhexidine Allergy; Infection; Rash

Intervention: Chlorhexidine gluconate (Drug)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: Celeste Chandonnet

Official(s) and/or principal investigator(s):
Celeste J Chandonnet, BSN CCRN CIC, Principal Investigator, Affiliation: Children's Hospital Boston
Cheryl Toole, MS RN NEA-BC, Principal Investigator, Affiliation: Children's Hospital Boston

Overall contact:
Celeste J Chandonnet, BSN CCRN CIC, Phone: 617-355-8076, Email: celeste.chandonnet@childrens.harvard.edu

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.

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

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Percentage of study participants with Adverse Event Rates Less than 10%

Secondary outcome: Change in 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 postmenstrual age (PMA) and 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 > than 36 weeks PMA or older, and < 2 months of age evidenced by adverse event rate < 10%. Hypothesis 2: Twice weekly CHG baths do not lead to rising (cumulative) CHG blood levels over time in a sample of infants > than 36 weeks PMA or older, and < 2 months of age.

Minimum age: 36 Weeks. Maximum age: 48 Weeks. Gender(s): Both.

Criteria:

Inclusion criteria.

- >/= 36 weeks postmenstrual age (gestational age + chronological age)

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- >/= 3 days of age

- Existing or soon to be placed, peripheral or surgical central venous catheter

- 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 > 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.

Celeste J Chandonnet, BSN CCRN CIC, Phone: 617-355-8076, Email: celeste.chandonnet@childrens.harvard.edu

Boston Children's Hospital, Boston, Massachusetts 02115, United States

Starting date: January 2015
Last updated: December 22, 2014