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Microbial Surveillance in Children Hospitalized for Cardiovascular Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00426894
First received: January 24, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

the purpose of this study is to determine whether children who are hospitalised waiting for cardiac surgery for several days in pediatric or pediatric surgery department acquire resistant microbial flora, thus necessitating broad spectrum antibiotics for perioperative prophylaxis.


Condition Intervention
Cardiac Surgery
Perioperative Prophylaxis
 Procedure: samples from nostrils, mouth, axillas, perianal area and postoperative wound

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Longitudinal Microbial Surveillance in Children Hospitalized for Cardiac Surgery Before the Operation and During Hospitalization

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Study Start Date: January 2007
Detailed Description:

Background

Guidelines for antimicrobial prophylaxis for cardiac surgery advise using first generation cephalosporin for those children coming from home. Large number of children that pass cardiac surgery in Hadassah University Hospital, Jerusalem, are hospitalized for several days before the operation in Pediatric Surgery department due to administrative reasons. These children receive broad spectrum antibiotics, vancomycin and ceftazidime, as a peri-operative prophylaxis, in order to prevent infection with hospital acquired flora with which they could become colonized with during this period. This policy causes exposure to broad spectrum antibiotics from the beginning in these children, and also providing an antimicrobial pressure in the intensive care unit, influencing the development of resistant flora.

There is no documentation that these children acquire resistant flora during there hospitalization in the pre-operative period. We suggest checking microbial flora in those children hospitalized for cardiac surgery, in order to determine the need for broad spectrum antimicrobial prophylaxis.

Goals

To check microbial flora in children hospitalized for cardiac surgery on different time points: on admission and during hospitalization in Pediatric Surgery Department, on admission to PICU (immediately after operation),after 3 - 5 days,when drains are extracted.

To document if there is a change in resistance pattern of microbial pathogens during these periods

To determine the optimal regimen for antimicrobial prophylaxis for those children who need to be hospitalized in this department before the operation

Methods

Surveillance cultures would be taken from children who are hospitalized for cardiac surgery on several time points:

  1. on admission to Pediatric Surgery or other department pre-operatively
  2. once weekly afterwards, if they continue to be hospitalized without surgery
  3. on admission to PICU after surgery
  4. during their subsequent hospitalization in PICU after 3 - 5 days
  5. on the day of drains extraction

These cultures will include the cultures of nostrils, throat,axillas, perineum and rectum and post operative wound.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All children and infants who are hospitalized in general pediatrics or pediatric surgery department before they undergo cardiac surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00426894

Contacts
Contact: Dina Averbuch, MD 972-50-7874940 dina8282@walla.co.il
Contact: Hadas Lemberg, PhD 972 2 6777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah University Hospital Not yet recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD     00 972 2 6776095     arik@hadassah.org.il    
Contact: Hadas Lemberg, PhD     00 972 2 6777572     lhadas@hadassah.org.il    
Principal Investigator: Diana Averbuch, MD            
Sub-Investigator: Shmuel Benenson, MD            
Sub-Investigator: Ido Yatsiv, MD            
Sub-Investigator: Eli Milgalter, MD            
Sub-Investigator: Matan J Cohen, MD MPh            
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Dina Averbuch, MD Hadassah University Hospital, Jerusalem, Israel
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00426894     History of Changes
Other Study ID Numbers: yael01-HMO-CTIL
Study First Received: January 24, 2007
Last Updated: January 24, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
surveillance cultures
children
cardiac surgery
perioperative prophylaxis

ClinicalTrials.gov processed this record on May 21, 2013