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NCT05379452 Clinical Trial

Outcomes of Neonates Born to Mothers With SARS-CoV-2 Infection in Shanghai

SARS-CoV2 Infection Clinical Trial

Official title:
Outcomes of Neonates Born to Mothers With SARS-CoV-2 Infection During the Outbreak of Omicron in Shanghai: a Cohort Study.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT05379452
Other study ID # CHFudanU_COVID19-2
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date January 1, 2023

Study information
Verified date December 2023
Source Children's Hospital of Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Since March 2022, there are an outbreak of SARS-CoV-2 infection (Omicron) in Shanghai. This cohort study aims to analysis the clinical outcomes of neonates born to mothers with SARS-CoV-2 infection.

Recruitment information / eligibility
Status Terminated
Enrollment 236
Est. completion date January 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 28 Days
Eligibility Inclusion Criteria: - Neonates born to mothers with SARS-CoV-2 infections. Exclusion Criteria: - Parents who rejected to participate in this study.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Children Hospital of Fudan University Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The death of newborns The date of discharge,an average of 4 weeks after the admission
Secondary The malformation rate of neonates born to mothers with SARS-CoV-2 infections Birth
Secondary The preterm delivery rate of neonates born to mothers with SARS-CoV-2 infections Birth
Secondary The brain injury rate of neonates born to mothers with SARS-CoV-2 infections within 7days after the admission
Secondary The development delay rate of neonates born to mothers with SARS-CoV-2 infections within 1 year after the admission
Secondary The Chinese standardized Denver Developmental Screening Test (DDST) in neonates born to mothers with SARS-CoV-2 infections Infants ( =35 weeks)are at 1 year after birth;Infants(< 35weeks) are at a corrected age of 1 year
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