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

Terminated

• Conditions: Neonatal Infection; Outcomes; SARS-CoV2 Infection

• Registration Number: NCT05379452
• Lead Sponsor: Children's Hospital of Fudan University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-05-16
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-18
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-27
• Last Update Posted: 2023-12-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

• Neonates born to mothers with SARS-CoV-2 infections.

Exclusion Criteria

• Parents who rejected to participate in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The death of newborns	The date of discharge，an average of 4 weeks after the admission

Secondary Outcome Measures

Name	Time	Method
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
The malformation rate of neonates born to mothers with SARS-CoV-2 infections	Birth
The brain injury rate of neonates born to mothers with SARS-CoV-2 infections	within 7days after the admission
The preterm delivery rate of neonates born to mothers with SARS-CoV-2 infections	Birth
The development delay rate of neonates born to mothers with SARS-CoV-2 infections	within 1 year after the admission

Trial Locations

Locations (1)

Children Hospital of Fudan University; 🇨🇳 Shanghai, China