Audiological evaluation of children with HIV

ISRCTN	ISRCTN28354627
DOI	https://doi.org/10.1186/ISRCTN28354627
Secondary identifying numbers	1.175.254/2015

Submission date: 25/01/2019
Registration date: 29/01/2019
Last edited: 28/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
People infected with the human immunodeficiency virus (HIV) are more likely to have hearing loss, as shown by some previous studies. However, there is no consensus about the age of hearing impairment, type of hearing loss and the real role of characteristics such as viral load (amount of virus in the blood) and the T CD4 cell count (number of an important type of cells of defense). The aim of this study is to assess the hearing status of children with HIV.

Who can participate?
Children with HIV aged 18 months to 11 years treated at a university hospital in Brazil, and children without HIV for comparison

What does the study involve?
Information on ear complaints (like ear infection, ear pain, difficulty in hearing, tinnitus, difficulty in word discrimination, and feeling of fullness in the ear), type and duration of antiretroviral therapy, viral load, and CD4+ cell count are obtained from the child’s caregiver. An ear examination and hearing test are performed.

What are the possible benefits and risks of participating?
The main benefit for the children involved was the early detection of hearing loss. The risks for participants were a little pain during the ear examination and hearing test if they moved their head.

Where is the study run from?
Hospital of the Federal University of Maranhão (Brazil)

When is the study starting and how long is it expected to run for?
April 2015 to September 2018

Who is funding the study?
FAPEMA (Fundação de Amparo à Pesquisa e ao Desenvolvimento Científico e Tecnológico do Estado do Maranhão)

Who is the main contact?
Prof. Janaína Pulcherio

Contact information

Prof Janaina Pulcherio
Scientific

Praça Gonçalves Dias, 21
São Luís
65020240
Brazil

Study information

Study design	Cross-sectional observational study
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Hospital
Study type	Diagnostic
Scientific title	Transient evoked otoacoustic emission in children infected with human immunodeficiency virus
Study objectives	HIV causes hearing loss.
Ethics approval(s)	Ethical Research Committee of Health Ministry of Brazil, Barão de Itapary Street, number 227, District: CENTER, São Luís, Maranhão, Brazil, Tel: +55 (98)2109-1250, Email: cep@huufma.br, 07/08/2015, protocol number 1.175.254/2015
Health condition(s) or problem(s) studied	HIV infection
Intervention	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 load, and CD4+ cell count were obtained from the caregiver. Otoscopy and transient evoked otoacoustic emission (TEOAE) testing were then performed.
Intervention type	Other
Primary outcome measure	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 outcome measures	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
Overall study start date	01/04/2015
Completion date	30/09/2018

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	18 Months
Upper age limit	11 Years
Sex	Both
Target number of participants	40
Key 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
Key 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
Date of first enrolment	01/05/2016
Date of final enrolment	30/06/2018

Locations

Countries of recruitment

Brazil

Study participating centre

Hospital of the Federal University of Maranhão

Barão de Itapary Street, number 227, District: Center
São Luís, Maranhão
65020240
Brazil

Sponsor information

FAPEMA
Government

Perdizes Street, number 05, square 37, District: Jardim Renascença
SÃO LUÍS, MARANHÃO
65075340
Brazil

Website	http://www.fapema.br/
"ROR"	https://ror.org/03vqm2n93

Funders

Funder type

Government

FAPEMA

No information available

Results and Publications

Intention to publish date	01/02/2019
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	The trialists intend to publish at BMC Medicine.
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Janaina Pulcherio (janabentivi.orl@gmail.com).