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

NCT02326467 | Completed Phase 1 Results DMC

• 1 other identifier: IRB-P00011128
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chlorhexidine Allergy; Infection; Rash

Keywords

chlorhexidine; safety; bath; rash; infant

Outcome Measures

Primary Outcomes (1)

• Percentage of Study Participants With Skin Reactions Less Than 10%

  1. Study RN's will perform a full body skin assessment for skin irritation or open areas prior to each bath. 2. Bedside RN's will complete skin assessments every 12 hours during the course of the study. 3. 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 Outcomes (1)

• The Number of Participants With Detectable CHG Blood Levels

  CHG blood levels will be assessed at baseline, then weekly for the duration of study participation (max 90 days)

Study Arms (1)

Chlorhexidine gluconate bath

EXPERIMENTAL

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

Interventions

Chlorhexidine gluconate DRUG

Bi-weekly chlorhexidine baths

Also known as: Sage® 2% Chlorhexidine Gluconate Cloth

Chlorhexidine gluconate bath

Eligibility Criteria

• Age: 36 Weeks - 48 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celeste Chandonnet: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Infections; Exanthema

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

The study was stopped early due to the unknown risks associated with CHG levels in relation to CHG bathing.

Results Point of Contact

• Title: Celeste Chandonnet
• Organization: Boston Children's Hospital

celeste.chandonnet@childrens.harvard.edu

781-216-0050

Study Officials

• Celeste J Chandonnet, BSN CCRN CIC

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Unit based Infection Prevention Nurse

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: December 29, 2014
• Study Start: February 1, 2016
• Primary Completion: September 13, 2018
• Study Completion: July 1, 2019
• Last Updated: July 27, 2021
• Results First Posted: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)