Hearing Problems in Children of Rheumatic Diseased Mothers

September 11, 2018 updated by: Fatma Ragab Mohasseb Ali, Assiut University

Assessment of Hearing in Children Born to Rheumatic Diseased Women Treated With Antimalarial Drugs During Pregnancy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

children (age 4 to 16 years) whose mothers have rheumatic diseases during pregnancy with gestational intake of antimalarial drugs as a treatment.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
children of rheumatic diseased mothers not on treatment
Diagnostic test: Audiometer
detection of hearing problems
children of rheumatic diseased mothers on antimalarial drugs
Diagnostic test: Audiometer
detection of hearing problems
children of normal mothers
Diagnostic test: Audiometer
detection of hearing problems

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dual channel audiometer
Time Frame: 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.
20 mimutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Fatma Ragab mohasseb, Phd, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2018

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

September 10, 2018

First Submitted That Met QC Criteria

September 11, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Actual)

September 12, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17100500

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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