ewborn hearing screening in neonates born to mothers with COVID-19 during pregnancy

Recruiting

• Conditions: Hearing screening of neonates born to women who were positive SARS-CoV-2 PCR during pregnancy; Automated auditory brainstem response (ABR); Otoacoustic emission (OAE); Newborn hearing screening; COVID-19; SARs-CoV-2; Vertical transmission

• Registration Number: TCTR20220714001
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-14
• Study Completion: 2022-08-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

1. Neonates born to mothers who were positive SARS-CoV-2 PCR during pregnancy or neonates born to healthy women
2. Neonates with normal ear canal
3. Singleton

Exclusion Criteria

1. Family of childhood hearing loss
2. Admitted in neonatal intensive care more than 5 days
3. Hyperbilirubinemia with exchange transfusion
4. Aminoglycoside administration for more than 5 days,
5. Asphyxia or hypoxic ischemic encephalopathy, extracorporeal membrane oxygenation (ECMO)
6. In utero infections of toxoplasmosis, rubella, cytomegalovirus, herpes, syphilis,Zika
7. Craniofacial malformation
8. Syndrome associated with hearing loss
9. Culture-positive infection associated with sensorineural hearing loss
10. Major birth head injury to skull (for example Skull fracture)
11. Small for gestational age (SGA)
12. Neonatal seizure
13. Positive PCR for SARS-CoV-2 neonates

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
newborn hearing screening after 48 hours of birth TEOAE, ABR

Secondary Outcome Measures

Name	Time	Method
n/a n/a n/a