Trial · NCT02326467
Pilot Study: Safety of Chlorhexidine (CHG) Baths in Patients Less Than 2 Months of Age
NCT02326467, Phase 1, Completed, Celeste Chandonnet; results first posted 2021-07-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pilot Study: Safety of Chlorhexidine (CHG) Baths in Patients Less Than 2 Months of Age. Trials, record NCT02326467. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02326467
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study: Safety of Chlorhexidine (CHG) Baths in Patients Less Than 2 Months of Age
- NCT number
- NCT02326467
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 10 participants, actual
- Lead sponsor
- Celeste Chandonnet
- Conditions
- Chlorhexidine Allergy, Infection, Rash
- Interventions
- Chlorhexidine gluconate
- First posted
- 2014-12-29
- Last updated
- 2021-07-27
- Results first posted
- 2021-07-27
- Limitations and caveats
- The study was stopped early due to the unknown risks associated with CHG levels in relation to CHG bathing.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | 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. |
| Secondary | 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) | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | All subjects were observed for adverse skin reactions related to CHG bathing. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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) | CHG levels were recorded in all participants. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Study Participants With Skin Reactions Less Than 10% | Chlorhexidine Gluconate Bath | AE Skin Reactions | 0 | Participants | |
| Percentage of Study Participants With Skin Reactions Less Than 10% | Chlorhexidine Gluconate Bath | AE Anemia | 2 | Participants | |
| The Number of Participants With Detectable CHG Blood Levels | Chlorhexidine Gluconate Bath | Participants with non-detectable CHG levels or CHG levels < 100 ng/mL for duration of study. | 2 | Participants | |
| The Number of Participants With Detectable CHG Blood Levels | Chlorhexidine Gluconate Bath | Participants with highest recorded CHG level equal to or < 1000 ng/mL for duration of study. | 4 | Participants | |
| The Number of Participants With Detectable CHG Blood Levels | Chlorhexidine Gluconate Bath | Participants with highest recorded CHG level > 1000 ng/mL for duration of study. | 3 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chlorhexidine Gluconate Bath | 10 | |
| Overall Study | COMPLETED | Chlorhexidine Gluconate Bath | 9 | |
| Overall Study | NOT COMPLETED | Chlorhexidine Gluconate Bath | 1 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Chlorhexidine Gluconate Bath | 2 | 9 | 2 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chlorhexidine Gluconate Bath | 0 | 9 |
| Total, other adverse events | Chlorhexidine Gluconate Bath | 2 | 9 |
| Total, serious adverse events | Chlorhexidine Gluconate Bath | 0 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02326467
GET https://conductscience.org/api/trials/v1/NCT02326467/registered