Condition category
Infections and Infestations
Date applied
25/01/2019
Date assigned
29/01/2019
Last edited
28/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Janaina Pulcherio

ORCID ID

Contact details

Praça Gonçalves Dias
21
São Luís
65020240
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.175.254/2015

Study information

Scientific title

Transient evoked otoacoustic emission in children infected with human immunodeficiency virus

Acronym

Study hypothesis

HIV causes hearing loss.

Ethics approval

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

Study design

Cross-sectional observational study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

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

Phase

Drug names

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 trial start date

01/04/2015

Overall trial end date

30/09/2018

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

01/05/2016

Recruitment end date

30/06/2018

Locations

Countries of recruitment

Brazil

Trial participating centre

Hospital of the Federal University of Maranhão
Barão de Itapary Street, number 227, District: Center
São Luís, Maranhão
65020240
Brazil

Sponsor information

Organisation

FAPEMA

Sponsor details

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

Sponsor type

Government

Website

http://www.fapema.br/

Funders

Funder type

Government

Funder name

FAPEMA

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trialists intend to publish at BMC Medicine.

IPD sharing statement
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).

Intention to publish date

01/02/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

BMC Medicine

Publication citations

Additional files

Editorial Notes