Hearing Problems in Children of Rheumatic Diseased Mothers

• Conditions: Hearing Disorders

• Registration Number: NCT03666910
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2018-09
• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-11
• Last Update Submitted: 2018-09-11
• Study First Posted: 2018-09-12
• Last Update Posted: 2018-09-12
• Study Start: 2018-10
• Primary Completion: 2019-10
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dual channel audiometer	20 mimutes	evaluate 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.