The Effect of Oral Candidiasis on the Speech Production, Feeding Skills, and Self-Concept of Children and Adolescents With Symptomatic HIV Infection
2 other identifiers
observational
50
1 country
1
Brief Summary
The main objectives of this study are: 1) to determine whether various levels of severity of oral candidiasis (thrush) in the child are associated with different levels of speech production, feeding skills, and self-concept, and 2) to assess the effect of the reduction of oral thrush over time on the speech function, feeding skills, and self-concept in HIV-infected patients who already are receiving various antifungal medications for treatment of their thrush (Note: Decisions regarding antifungal therapy are made completely independent from this study). Children with HIV disease, ages 6-21 years, who have oral thrush are eligible to paricipate in the study. The child and his/her parent will be asked to complete a variety of measures at specific time intervals over approximately one month during visits to the National Institutes of Health for treatment on other protocols. First, a nurse will rate the location and severity of thrush in the child's mouth. Then the parent will complete questionnaires assessing the effect of oral thrush on the child's feeding and speech skills and everyday functioning. Finally, the child will be administered a brief speech and oral-motor evaluation and will complete some questionnaires about how the thrush affects his/her day-to-day activities and self-concept. The results of this study may help to better understand the cause of expressive language deficits observed in some children with HIV infection. More specifically, it will determine if any speech and feeding problems of HIV-infected children are associated with oral thrush. Learning more about the impact of oral thrush on the speech, feeding, and the self-concept of children with HIV disease may be used for parent and patient education and to develop rehabilitative recommendations to benefit HIV-infected patients with oral thrush.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 1995
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 1995
CompletedFirst Submitted
Initial submission to the registry
November 3, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2000
CompletedFirst Posted
Study publicly available on registry
December 10, 2002
CompletedMarch 4, 2008
July 1, 1999
November 3, 1999
March 3, 2008
Conditions
Keywords
Eligibility Criteria
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Sponsors & Collaborators
Study Sites (1)
National Cancer Institute (NCI)
Bethesda, Maryland, 20892, United States
Related Publications (3)
Epstein LG, Sharer LR, Oleske JM, Connor EM, Goudsmit J, Bagdon L, Robert-Guroff M, Koenigsberger MR. Neurologic manifestations of human immunodeficiency virus infection in children. Pediatrics. 1986 Oct;78(4):678-87.
PMID: 2429248BACKGROUNDPressman H. Communication disorders and dysphagia in pediatric AIDS. ASHA. 1992 Jan;34(1):45-7. No abstract available.
PMID: 1540256BACKGROUNDWolters PL, Brouwers P, Moss HA, Pizzo PA. Differential receptive and expressive language functioning of children with symptomatic HIV disease and relation to CT scan brain abnormalities. Pediatrics. 1995 Jan;95(1):112-9.
PMID: 7770287BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 3, 1999
First Posted
December 10, 2002
Study Start
August 1, 1995
Study Completion
June 1, 2000
Last Updated
March 4, 2008
Record last verified: 1999-07