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Audiological evaluation of children with HIV

Transient evoked otoacoustic emission in children infected with human immunodeficiency virus

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN28354627
Enrollment
40
Registered
2019-01-29
Start date
2016-05-01
Completion date
Unknown
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV infection Infections and Infestations Human immunodeficiency virus [HIV] disease

Interventions

Data on complaints (like otorrhea, ear pain, difficulty in hearing, tinnitus, difficulty in word discrimination, and feeling of fullness in the ear), type and duration of antiretroviral therapy, viral

Sponsors

FAPEMA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children living with HIV aged 18 months to 11 years 2. Attending the Hospital of the Federal University of Maranhão, in Northeast Brazil

Exclusion criteria

Exclusion criteria: 1. Family history of deafness 2. Consanguineous parents 3. Psychomotor developmental delay due to neurological disease 4. Craniofacial anomalies 5. Prematurity 6. Hospitalization to a neonatal intensive care unit 7. Meningitis 8. Treatment with chemotherapy 9. Perinatal co-infection (toxoplasmosis, rubella, cytomegalovirus, syphilis, herpes, HTLV-1, or viral hepatitis B and C), acute infection (external or middle ear) 10. Child uncooperative or aggressive

Design outcomes

Primary

MeasureTime frame
Assessed at a single timpepoint: 1. Otologic complaints (like otorrhea, ear pain, difficulty in hearing, tinnitus, difficulty in word discrimination, and feeling of fullness in the ear) assessed using caregiver interview 2. Ear anatomy assessed using otoscopy 3. Hearing assessed using transient evoked otoacoustic emission (TEOAE) testing

Secondary

MeasureTime frame
Assessed at a single timpepoint: 1. Viral load, assessed using caregiver interview (the last test performed) 2. CD4+ cell count, assessed using caregiver interview (the last test performed) 3. Details of anti-retroviral therapy, assessed using caregiver interview

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026