Clinical trial NCT03666910: Hearing Problems in Children of Rheumatic Diseased Mothers
Official title: Assessment of Hearing in Children Born to Rheumatic Diseased Women Treated With Antimalarial Drugs During Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hearing Disorders
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 90
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dual channel audiometer
timeFrame: 20 mimutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Fatma Ragab mohasseb, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.