Hearing Problems in Children of Rheumatic Diseased Mothers

Hearing Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03666910
• Other study ID #: 17100500
• Status: Not yet recruiting
• Start date: October 2018
• Est. completion date: December 2019

Study information

• Verified date: September 2018
• Source: Assiut University
• Contact: Mohamed Salama Bakr, Professor
• Phone: 1006550289
• Email: mohamedsalamabakr[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Disorders

Intervention

Diagnostic Test:
• Audiometer
detection of hearing problems

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

Baldwin C, Avina-Zubieta A, Rai SK, Carruthers E, De Vera MA. Disease-modifying anti-rheumatic drug use in pregnant women with rheumatic diseases: a systematic review of the risk of congenital malformations. Clin Exp Rheumatol. 2016 Mar-Apr;34(2):172-83. Epub 2016 Mar 3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dual channel audiometer	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