Completed

The Effect of Oral Candidiasis on the Speech Production, Feeding Skills, and Self-Concept of Children and Adolescents With Symptomatic HIV Infection

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What is being collected

Data Collection

Who is being recruted

Blood-Borne Infections+29

+ Urogenital Diseases

+ Genital Diseases

See all eligibility criteria
How is the trial designed

Observational
Study Start: August 1995
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1995

Actual date on which the first participant was enrolled.

Language impairments in children with symptomatic HIV infection are associated with the direct effects of HIV on the central nervous system (CNS). Furthermore, expressive language is more vulnerable to the effects of HIV compared to receptive language (Wolters, et al., 1995). Several factors, however, are likely to be involved in producing the expressive language impairments observed in the HIV-infected pediatric population. Oral candidiasis (thrush), a fungal infection in the oral cavity that frequently appears in HIV-infected children (Walsh, 1994), also may contribute to speech and language deficits depending on the severity of the thrush. Feeding skills and self-concept may be negatively affected by oral thrush as well. The effect of oral candidiasis on the speech production, feeding skills, and self-concept of children and adolescents with HIV infection will be examined in this pilot study. Several disciplines (Neuropsychology, Speech, Nursing, and Infectious Disease) will be involved to investigate the severity of oral candidiasis on various aspects of everyday behavior. Interdisciplinary assessment of the ramifications of oral thrush on speech production and feeding skills have not been conducted to date in children or adolescents infected with HIV. Most studies have assessed only single dimensions or functions such as language or they have yielded only descriptive data, for example, regarding the severity of oral thrush. This pilot study, however, will investigate the association between oral thrush and speech and feeding dysfunction using some newly-developed measures. The study will also examine whether oral candidiasis may influence the self-concept of children and adolescents with HIV infection.

NCT00001448
Principal SponsorNational Cancer Institute (NCI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesBacterial Infections and MycosesMental DisordersCandidiasisCommunicable DiseasesCommunication DisordersImmunologic Deficiency SyndromesImmune System DiseasesInfectionsLanguage DisordersStomatognathic DiseasesMouth DiseasesMycosesNervous System DiseasesNeurologic ManifestationsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsNeurobehavioral ManifestationsFeeding and Eating DisordersBehaviorCandidiasis, OralSpeech DisordersHIV Infections

Criteria

Children and adolescents with HIV infection, ages 6 through 21 years of age, who are treated in other protocols at the Pediatric Branch of the National Cancer Institute (NCI) and have oral candidiasis as determined by the Pediatric Nurse Practitioners, are eligible to participate in this study. Children and adolescents with infections or diseases other than candidiasis affecting the oral cavity as determined by the PNP's during the physical exam will be excluded from the study. Furthermore, patients who are identified by the speech pathologist to have oro-facial structural and/or functional abnormalities that cause a significant disturbance in speech, voice, or swallowing will be excluded. Children will also not be able t participate in the study if they cannot understand the measures, even if the questions are read to them, which will be determined by the Neuropsychology staff.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Cancer Institute (NCI)

Bethesda, United StatesOpen National Cancer Institute (NCI) in Google Maps
CompletedOne Study Center