Preventive Oral Care
Primary Purpose
Fever, Respiratory Infection
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
oral care
Sponsored by
About this trial
This is an interventional prevention trial for Fever focused on measuring antibiotics, Hospitalization, oral care
Eligibility Criteria
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
NCT ID
NCT00800696
First Posted
November 30, 2008
Last Updated
December 27, 2018
Sponsor
Shaare Zedek Medical Center
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Withdrawn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
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Preventive Oral Care
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