Hearing Problems in Children of Rheumatic Diseased Mothers

Assiut University

Status: Unknown

Conditions: Hearing Disorders

Treatments: Diagnostic Test: Audiometer

Study type: Observational

Funder types: Other

Identifiers

NCT03666910

17100500

Details and patient eligibility

About

Evaluation of the hearing functions of children born to rheumatic diseased mothers who received gestational antimalarial drugs versus those didn't receive gestational antimalarials drugs compared with normal healthy children.

Full description

Rheumatic diseases are autoimmune illnesses characterized by tissue damage, caused by abnormal immunologic reaction against own cells, tissues or organs.Many of these rheumatic diseases preferentially occur in women during the childbearing age.

The transplacental passage of maternal antibody may result in a variety of adverse fetal effects including thrombocytopenia, neutropenia, hemolysis and thyroid disease. Both fetal hypo and hyper thyroidism may occur and maternal hypothyroidism particularly during the 1st trimester is associated with impaired fetal neurological development and delayed mental and motor development.

Hydroxychloroquine (CQ), the hydroxyl derivative of chloroquine, is an antimalarial agent which is widely used, either alone or in combination with other agents, in the treatment of SLE, rheumatoid arthritis (RA) and various other autoimmune diseases.

Hydroxychloroquine is safe during pregnancy, as it is not associated with an increased rate of congenital malformations. However, isolated cases of ocular (retinal pigment deposits) and auditory abnormalities were reported.

An increase in high-frequency hearing threshold is the earliest change in the auditory function for most drug induced hearing losses, including the irreversible damage caused by antimalarials.

The investigators therefore will use audiological methods for detection of hearing impairment in children delivered for mothers receiving antimalarials during pregnancy with rheumatic diseases.

Enrollment: 90 estimated patients

Sex: All

Ages: 4 to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• children males & females
• Age 4 to 16 years.
• whose mothers have rheumatic diseases during pregnancy with gestational intake of antimalarial drugs as a treatment.

Exclusion criteria

• Prematurity, history of prenatal, natal or post natal medical problems.
• Family history +ve.
• Consanguinity +ve.
• Gestational intake of other ototoxic drugs.
• Use of antimalarial due to diseases other than rheumatic diseases.
• Administration of antimalarial before pregnancy.
• Children who have middle ear disorders.

Trial design

90 participants in 3 patient groups

children of rheumatic diseased mothers not on treatment

Treatment:

Diagnostic Test: Audiometer

children of rheumatic diseased mothers on antimalarial drugs

Treatment:

Diagnostic Test: Audiometer

children of normal mothers

Treatment:

Diagnostic Test: Audiometer