Phase 1
N=10
Pilot Study: Safety of Chlorhexidine (CHG) Baths in Patients Less Than 2 Months of Age
Chlorhexidine Allergy · Infection · Rash
Bottom Line
View on ClinicalTrials.gov: NCT02326467 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Percentage of Study Participants With Skin Reactions Less Than 10% — 0; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Chlorhexidine gluconate (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Celeste Chandonnet
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Study Participants With Skin Reactions Less Than 10% |
0; 2 | — |
| SECONDARY The Number of Participants With Detectable CHG Blood Levels |
2; 4; 3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02326467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.