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Effectiveness of Chlorhexidine Bathing in the Neonatal Intensive Care Unit

NCT02537964 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-10-22

No results posted yet for this study

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

Conditions

  • Infectious Disease Transmission

Interventions

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

Sponsors & Collaborators

  • Shaare Zedek Medical Center

    lead OTHER

Principal Investigators

  • Maskit Bar-Meir, MD · Shaare Zedek Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
10 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2020-10-01
Completion
2020-10-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02537964 on ClinicalTrials.gov