Trial Outcomes & Findings for Pilot Study: Safety of Chlorhexidine (CHG) Baths in Patients Less Than 2 Months of Age (NCT NCT02326467)
NCT ID: NCT02326467
Last Updated: 2021-07-27
Results Overview
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.
COMPLETED
PHASE1
10 participants
Adverse Events assessed every 12 hours for the duration of study participation (max 90 days)
2021-07-27
Participant Flow
Of the ten subjects enrolled, one subject withdrew prior to any interventions per parental request.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Pilot Study: Safety of Chlorhexidine (CHG) Baths in Patients Less Than 2 Months of Age
Baseline characteristics by cohort
| Measure |
Chlorhexidine Gluconate Bath
n=9 Participants
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
|
|---|---|
|
Type of Central Venous Line
Broviac
|
1 Participants
n=5 Participants
|
|
Type of Central Venous Line
Umbilical
|
1 Participants
n=5 Participants
|
|
Age, Continuous
PMA (Weeks)
|
40 Weeks
n=5 Participants
|
|
Age, Continuous
|
21 Age (Days)
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Weight Demographics
Birth Weight
|
2840 Grams
n=5 Participants
|
|
Weight Demographics
Weight at Enrollment
|
2840 Grams
n=5 Participants
|
|
Type of Central Venous Line
PICC
|
6 Participants
n=5 Participants
|
|
Type of Central Venous Line
Right Atrium
|
1 Participants
n=5 Participants
|
|
Diagnosis
Coarctation of the Aorta
|
1 Participants
n=5 Participants
|
|
Diagnosis
Duodenal Atresia
|
1 Participants
n=5 Participants
|
|
Diagnosis
Esophageal Atresia
|
1 Participants
n=5 Participants
|
|
Diagnosis
Esophageal Atresia/Tracheal Esophageal Fistula
|
1 Participants
n=5 Participants
|
|
Diagnosis
Gastroschisis
|
2 Participants
n=5 Participants
|
|
Diagnosis
Hypoplastic Left Heart Syndrome
|
1 Participants
n=5 Participants
|
|
Diagnosis
Laryngeal Cleft (Type III)
|
1 Participants
n=5 Participants
|
|
Diagnosis
Transposition of the Great Arteries
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Adverse Events assessed every 12 hours for the duration of study participation (max 90 days)Population: All subjects were observed for adverse skin reactions related to CHG bathing.
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.
Outcome measures
| Measure |
Chlorhexidine Gluconate Bath
n=9 Participants
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
|
|---|---|
|
Percentage of Study Participants With Skin Reactions Less Than 10%
AE Anemia
|
2 Participants
|
|
Percentage of Study Participants With Skin Reactions Less Than 10%
AE Skin Reactions
|
0 Participants
|
SECONDARY outcome
Timeframe: CHG blood levels will be assessed at baseline, then weekly for the duration of study participation (max 90 days)Population: CHG levels were recorded in all participants.
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.
Outcome measures
| Measure |
Chlorhexidine Gluconate Bath
n=9 Participants
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
|
|---|---|
|
The Number of Participants With Detectable CHG Blood Levels
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
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
Participants with highest recorded CHG level > 1000 ng/mL for duration of study.
|
3 Participants
|
Adverse Events
Chlorhexidine Gluconate Bath
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Chlorhexidine Gluconate Bath
n=9 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
22.2%
2/9 • Number of events 2 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place