Preventive Oral Care

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Shaare Zedek Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00800696
First received: November 30, 2008
Last updated: April 20, 2011
Last verified: April 2011

November 30, 2008
April 20, 2011
September 2010
September 2013   (final data collection date for primary outcome measure)
Hospitalization days per year [ Time Frame: year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00800696 on ClinicalTrials.gov Archive Site
Fever [ Time Frame: year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Preventive Oral Care
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Fever
  • Respiratory Infection
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
  • 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.
    Intervention: Procedure: oral care
  • No Intervention: control
    continue to receive oral care as performed today.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
66
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clients who receive gastrostomy feedings only
  • ALEH Infirmary

Exclusion Criteria:

  • Oral Feeding
Both
3 Months to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00800696
58/08
Not Provided
Akiva Ehrlich RN, BSN, MPA, ALEH Infirmary
Shaare Zedek Medical Center
Not Provided
Not Provided
Shaare Zedek Medical Center
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP