Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 415 for:    shaare zedek

Effectiveness of Chlorhexidine Bathing in the Neonatal Intensive Care Unit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02537964
Recruitment Status : Recruiting
First Posted : September 2, 2015
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Maskit Bar-Meir, Shaare Zedek Medical Center

Brief Summary:

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

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Time to colonization [ Time Frame: 2 years ]
    Time to colonization with MDRO during the intervention periods compared with the control periods.

  3. 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]



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • infants weighing ≥1500 grams and >=10 days of age
  • parents' informed consent

Exclusion Criteria:

  • infants weighing <1500 grams or <10days of age;
  • parents' refusal to sign informed consent.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Maskit Bar-Meir, MD 972-2-6555545 mbarmeir@gmail.com

Locations
Layout table for location information
Israel
Shaare-Zedek Medical Center Recruiting
Jerusalem, Israel
Contact: Maskit Bar-Meir, MD       mbarmeir@gmail.com   
Contact: Irina Schores, MD       irina155@walla.co.il   
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Maskit Bar-Meir, MD Shaare Zedek Medical Center

Layout table for additonal information
Responsible Party: Dr. Maskit Bar-Meir, attending physician, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02537964     History of Changes
Other Study ID Numbers: 0018-15-SZMC
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr. Maskit Bar-Meir, Shaare Zedek Medical Center:
chlorhexidine

Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Infection
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents