Infection Clinical Trial
Official title:
Pilot Study: Safety of Chlorhexidine (CHG) Baths in Patients Less Than 2 Months of Age
Verified date | July 2021 |
Source | Boston Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | July 1, 2019 |
Est. primary completion date | September 13, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 36 Weeks to 48 Weeks |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Celeste Chandonnet |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Study Participants With Skin Reactions Less Than 10% | Study RN's will perform a full body skin assessment for skin irritation or open areas prior to each bath.
Bedside RN's will complete skin assessments every 12 hours during the course of the study. 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 | The Number of Participants With Detectable CHG Blood Levels | To monitor for absorption into the blood, a single CHG level will be obtained at baseline and then weekly on Fridays for the remainder of the study for each study participant. A CHG level will also be drawn when an infant is removed from the study in response to an adverse reaction. Of note, a threshold for safe, normal or toxic CHG level is not known, thus we will closely monitor blood levels and convene a meeting of the Data Safety and Monitoring Committee (DSMC) if adverse reactions develop in association with elevated blood levels. | CHG blood levels will be assessed at baseline, then weekly for the duration of study participation (max 90 days) |
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