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Preventive Oral Care

Primary Purpose

Fever, Respiratory Infection

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
oral care
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fever focused on measuring antibiotics, Hospitalization, oral care

Eligibility Criteria

3 Months - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clients who receive gastrostomy feedings only
  • ALEH Infirmary

Exclusion Criteria:

  • Oral Feeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    oral care

    control

    Arm Description

    intervention: The study group will have their teeth brushed three times a day by the nursing staff by using a suction connected toothbrush, daily examination of the oropharynx by the nursing staff, and use of chlorhexidine varnish or another suitable antibacterial agent in the oropharynx.

    continue to receive oral care as performed today.

    Outcomes

    Primary Outcome Measures

    Hospitalization days per year

    Secondary Outcome Measures

    Fever

    Full Information

    First Posted
    November 30, 2008
    Last Updated
    December 27, 2018
    Sponsor
    Shaare Zedek Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00800696
    Brief Title
    Preventive Oral Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    this study was not initiated due to lack of funding
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    September 2017 (Anticipated)
    Study Completion Date
    September 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shaare Zedek Medical Center

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of the investigators project is to examine if the investigators may affect a reduction in respiratory infections in a pediatric long term care facility by institution of a comprehensive oral care program. The investigators wish to base their project on work such as of Yoneyama et al 2002, which hypothesized and showed that "silent" aspiration of oropharyngeal contents is a causative factor in development of respiratory infection in elderly institutionalized clients. It was found that an advanced oral hygiene program greatly reduced the incidence of respiratory infection. Although no similar research projects were found to have involved children, the investigators hope that a similar program of oral care will allow the investigators to likewise reduce the incidence of respiratory infection among the pediatric clients in our facility. The investigators propose to examine two groups of children which are fed by gastrostomy feedings only. One group will continue to receive oral care as performed today. The study group will have their teeth brushed three times a day by the nursing staff by using a suction connected toothbrush, daily examination of the oropharynx by the nursing staff, and use of chlorhexidine varnish or another suitable antibacterial agent in the oropharynx. The investigators will retrospectively examine our records (a 12 month period) for febrile days, antibiotic use and hospitalization days due to respiratory causes. The investigators will then compare these to the febrile days, antibiotic use and hospitalizations to the 12 month period [post implementation of the oral care program. The importance of this program is to examine whether by implementation of a relatively inexpensive and low-tech intervention may meaningfully reduce the morbidity and mortality due to respiratory infection among our clients (which from our experience is the main cause of morbidity and mortality in the investigators institution). The investigators expect that by reducing the incidence of respiratory disease among our clients that the investigators will greatly reduce suffering among the children and their families, improve their quality of life and ease the financial and organizational burdens as a result of caring for respiratory infections. As was noted before, no prior research was found which studied the pediatric population in a long term care facilities. It is our belief that this project represents a unique research opportunity which may bring great benefit to the children and caregivers.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fever, Respiratory Infection
    Keywords
    antibiotics, Hospitalization, oral care

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    oral care
    Arm Type
    Experimental
    Arm Description
    intervention: The study group will have their teeth brushed three times a day by the nursing staff by using a suction connected toothbrush, daily examination of the oropharynx by the nursing staff, and use of chlorhexidine varnish or another suitable antibacterial agent in the oropharynx.
    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    continue to receive oral care as performed today.
    Intervention Type
    Procedure
    Intervention Name(s)
    oral care
    Intervention Description
    The study group will have their teeth brushed three times a day by the nursing staff by using a suction connected toothbrush, daily examination of the oropharynx by the nursing staff, and use of chlorhexidine varnish or another suitable antibacterial agent in the oropharynx
    Primary Outcome Measure Information:
    Title
    Hospitalization days per year
    Time Frame
    year
    Secondary Outcome Measure Information:
    Title
    Fever
    Time Frame
    year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clients who receive gastrostomy feedings only ALEH Infirmary Exclusion Criteria: Oral Feeding

    12. IPD Sharing Statement

    Learn more about this trial

    Preventive Oral Care

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