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screening of hearing loss in high risk infants

To Study Burden Of Hearing Loss And To Find Efficacy Of OAE And BERA As Screening Tools For Hearing In High Risk Infants - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/11/077475
Enrollment
350
Registered
2024-11-28
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Q359- Cleft palate, unspecified Health Condition 2: Q249- Congenital malformation of heart,unspecified Health Condition 3: Q369- Cleft lip, unilateral Health Condition 4: Q039- Congenital hydrocephalus, unspecified Health Condition 5: Q169- Congenital malformation of ear causing impairment of hearing, unspecified Health Condition 6: O169- Unspecified maternal hypertension,unspecified trimester Health Condition 7: P159- Birth injury, unspecified Health Condition 8: P220- Respi

Interventions

None listed

Sponsors

Department of health research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a. Family history of sensorineural hearing loss. b. In utero infection (cytomegaly virus, rubella, syphilis, herpes simplex or toxoplasmosis) c. Infants with birth weight less than 2.5 kg and more than 4.0 kg, Birth less than 37 weeks of gestation and more than 42 weeks of gestation Small or large for gestational age. d. Mother and infants on ototoxic medicines (aminoglycosides, loop diuretics) e. Apgar score (0-4 at 1 min, 0-6 at 5 minutes), mechanical ventilation more than 5 days f. Infants with Respiratory distress, cyanosis, bacterial meningitis, Seizure disorders otitis media, Congenital heart disease, Craniofacial animalia, hyperbilirubinemia g. Infants’ Congenital malformation, Microcephaly, Birth asphyxia, Cerebral palsy, Mental Retardation, Cleft lip or palate, Hydrocephalus. h. Infants of mother’s who had postdate pregnancy ( >42 weeks), TORCH Sexually transmitted infections, Diabetes, hypertension, Vaginal bleeding

Exclusion criteria

Exclusion criteria: 1. Parents of those subjects who do not give consent to BERA. 2. Infants with Head injury. 3. Subject who are severely ill.

Design outcomes

Primary

MeasureTime frame
Figure out the prevalence of hearing impairment in High Risk InfantsTimepoint: 9 months

Secondary

MeasureTime frame
Need of Newborn hearing screening as an essential tool to reduce hearing disability and evaluate the effectiveness of early screening and intervention in rajasthanTimepoint: 3 months

Countries

India

Contacts

Public ContactDr Mahima Sharma

RUHS,CMS Jaipur

drmahima1980@gmail.com9413980333

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026