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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.
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..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine gluconate | Drug | Bi-weekly chlorhexidine baths |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Study Participants With Skin Reactions Less Than 10% |
| Adverse Events assessed every 12 hours for the duration of study participation (max 90 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria.
Exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Celeste J Chandonnet, BSN CCRN CIC | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
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Of the ten subjects enrolled, one subject withdrew prior to any interventions per parental request.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chlorhexidine Gluconate Bath | All subjects were to receive a bath twice a week with 2% CHG bathing cloths. The baths were to 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 monitored 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 were to be monitored for associated adverse events and accumulation. Chlorhexidine gluconate: Bi-weekly chlorhexidine baths |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Chlorhexidine Gluconate Bath | All subjects received a bath twice a week with 2% CHG bathing cloths. The baths were to 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 monitored 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 were to be monitored for associated adverse events and accumulation. Chlorhexidine gluconate: Bi-weekly chlorhexidine baths |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Study Participants With Skin Reactions Less Than 10% |
| All subjects were observed for adverse skin reactions related to CHG bathing. | Posted | Count of Participants | Participants | Adverse Events assessed every 12 hours for the duration of study participation (max 90 days) |
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The adverse event data collection period for enrolled subjects were collected up to a maximum of 40 days.
All subjects were monitored for adverse events including skin reactions, anemia and significant changes to baseline lab values.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chlorhexidine Gluconate Bath | All subjects received a bath twice a week with 2% CHG bathing cloths. The baths were followed by blood sampling for CHG levels prior to initiation of baths and every Friday for the duration of study participation. The study team monitored 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 were monitored for associated adverse events and accumulation. Chlorhexidine gluconate: Bi-weekly chlorhexidine baths |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment | One subject experienced anemia that was identified with pre-operative lab work. The subject was placed on study hold for anemia and post-op recovery. The anemia resolved post-op. This was not deemed a serious adverse event. |
The study was stopped early due to the unknown risks associated with CHG levels in relation to CHG bathing.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Celeste Chandonnet | Boston Children's Hospital | 781-216-0050 | celeste.chandonnet@childrens.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2016 | Apr 21, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 30, 2017 | Jul 17, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D005076 | Exanthema |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
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| CHG blood levels will be assessed at baseline, then weekly for the duration of study participation (max 90 days) |
| Weeks |
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| Age, Continuous | Median | Full Range | Age (Days) |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Weight Demographics | Median | Full Range | Grams |
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| Type of Central Venous Line | Count of Participants | Participants |
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| Diagnosis | Count of Participants | Participants |
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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.
Chlorhexidine gluconate: Bi-weekly chlorhexidine baths
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| 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 levels were recorded in all participants. | Posted | Count of Participants | Participants | CHG blood levels will be assessed at baseline, then weekly for the duration of study participation (max 90 days) |
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| 0 |
| 9 |
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| 9 |
| 2 |
| 9 |
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