Sponsor study identifier
interventional
24
1 country
1
Study Start
September 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 1, 2020
Actual (reported)Study Completion
October 1, 2020
Actual (reported)This is a prospective, controlled; crossover study of daily bathing with no-rinse, 2% chlorhexidine gluconate (CHG) impregnated washcloths versus bathing with water/soap or water according to gestational age and weight (e.g. standard bathing). The trial will take place in the Neonatal intensive care unit (NICU). Baseline data ragarding bloodstream infections (BSI) and colonization with multidrug resistant orgnisms (MDRO) will be collected for 3-6 months prior to patient enrollment. In the preliminary phase of the study we will establish the safety of chlorhexidine bathing using Clinell ® Chlorhexidine wash cloths on three groups of patients: term infants admitted to the NICU; late preterm infants (34-37 weeks); preterm infants 30-34 weeks of gestation. Interim analysis for adverse events will be performed after each group of patients. In the subsequent phases of the study, all infants admitted to the NICU and enrolled in the study will be bathed three times a week with Chlorhexidine wash cloths during the initial 6-months study period (intervention), followed by standard bathing during the second 6-months period, then again intervention period for 6 months and standard bathing for 6-months. Total study period- 3 years. Data collection will include all bloodstream infections as well as surveillance cultures
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 28, 2015
Actual (reported)September 2, 2015
Actual (reported)September 2016
Date type not reportedThis date has not been verified as actual or estimated.
October 1, 2020
Actual (reported)October 1, 2020
Actual (reported)bacteremia episodes per 1000 patient days
Number of bacteremia events per 1000 patient days during the intervention periods compared with the control periods.
3 years
Colonization with resistant bacteria
2 years
Time to colonization
2 years
colonization with resistant bacteria
2 years
Intervention: All infants in the NICU eligible for the study will be assigned for bathing three times a week with washcloths impregnated with 2% chlorhexidine gluconate
Standard bathing with water +/- mild soap according to age and gestational week
All infants in the NICU eligible for the study will be assigned for bathing three times a week with washcloths impregnated with 2% chlorhexidine gluconate
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Shaare-Zedek Medical Center
Jerusalem, Israel
Maskit Bar-Meir, MD
Shaare Zedek Medical Center
24 participants (actual enrollment reported by the registry).
First Submitted
July 28, 2015
First Posted
September 2, 2015
Study Start
September 2016
Date type not reportedThis date has not been verified as actual or estimated.
Eban II: Intervention for HIV Sero-Discordant Couples
Contact the study team to confirm eligibility.
Primary Completion
October 1, 2020
Actual (reported)Study Completion
October 1, 2020
Actual (reported)Last Updated
October 22, 2020
Record last verified: 2020-10
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Source: ClinicalTrials.gov.
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