Preventive Oral Care
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Fever Respiratory Infection |
Procedure: oral care |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
- Hospitalization days per year [ Time Frame: year ] [ Designated as safety issue: No ]
- Fever [ Time Frame: year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 66 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: oral care
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.
|
Procedure: oral care
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
|
|
No Intervention: control
continue to receive oral care as performed today.
|
Eligibility| Ages Eligible for Study: | 3 Months to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clients who receive gastrostomy feedings only
- ALEH Infirmary
Exclusion Criteria:
- Oral Feeding
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Akiva Ehrlich RN, BSN, MPA, ALEH Infirmary |
| ClinicalTrials.gov Identifier: | NCT00800696 History of Changes |
| Other Study ID Numbers: | 58/08 |
| Study First Received: | November 30, 2008 |
| Last Updated: | April 20, 2011 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by Shaare Zedek Medical Center:
|
antibiotics Hospitalization oral care |
Additional relevant MeSH terms:
|
Respiratory Tract Infections Infection Respiratory Tract Diseases Anti-Bacterial Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013