Effectiveness of Chlorhexidine Bathing in the Neonatal Intensive Care Unit
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|ClinicalTrials.gov Identifier: NCT02537964|
Recruitment Status : Recruiting
First Posted : September 2, 2015
Last Update Posted : April 8, 2019
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
|Condition or disease||Intervention/treatment||Phase|
|Infectious Disease Transmission||Other: washcloths impregnated with 2% chlorhexidine gluconate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Effectiveness of Chlorhexidine Bathing in Reducing Nosocomial Infections in the Neonatal Intensive Care Unit|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
Experimental: Chlorhexidine bath
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
Other: washcloths impregnated with 2% chlorhexidine gluconate
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
Other Name: Clinell ® Chlorhexidine wash cloths, GAMA healthcare
No Intervention: Standard bathing
Standard bathing with water +/- mild soap according to age and gestational week
- bacteremia episodes per 1000 patient days [ Time Frame: 3 years ]Number of bacteremia events per 1000 patient days during the intervention periods compared with the control periods.
- Colonization with resistant bacteria [ Time Frame: 2 years ]Number of new patients colonized with MRSA, VRE, CRAB or ESBL per total number of patients, monthly range and variance.
- Time to colonization [ Time Frame: 2 years ]Time to colonization with MDRO during the intervention periods compared with the control periods.
- colonization with resistant bacteria [ Time Frame: 2 years ]Number of new patients colonized with MRSA, VRE, CRAB or ESBL per 1000 eligible patient days [ Total patient days - total patient days for patients identified with MDRO]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537964
|Contact: Maskit Bar-Meir, MDemail@example.com|
|Principal Investigator:||Maskit Bar-Meir, MD||Shaare Zedek Medical Center|