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

December 27, 2023 updated by: Children's Hospital of Fudan University

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

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

236

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 201102
        • Children Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Neonates born to mothers with SARS-CoV-2 infections will be recruited from all the designated hospital during the outbreak of Omicron in Shanghai.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Parents who rejected to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The death of newborns
Time Frame: The date of discharge，an average of 4 weeks after the admission
The date of discharge，an average of 4 weeks after the admission

Secondary Outcome Measures

Outcome Measure
Time Frame
The malformation rate of neonates born to mothers with SARS-CoV-2 infections
Time Frame: Birth
Birth
The preterm delivery rate of neonates born to mothers with SARS-CoV-2 infections
Time Frame: Birth
Birth
The brain injury rate of neonates born to mothers with SARS-CoV-2 infections
Time Frame: within 7days after the admission
within 7days after the admission
The development delay rate of neonates born to mothers with SARS-CoV-2 infections
Time Frame: within 1 year after the admission
within 1 year after the admission
The Chinese standardized Denver Developmental Screening Test (DDST) in neonates born to mothers with SARS-CoV-2 infections
Time Frame: Infants ( ≥35 weeks）are at 1 year after birth;Infants（< 35weeks） are at a corrected age of 1 year
Infants ( ≥35 weeks）are at 1 year after birth;Infants（< 35weeks） are at a corrected age of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

May 16, 2022

First Submitted That Met QC Criteria

May 16, 2022

First Posted (Actual)

May 18, 2022

Study Record Updates

Last Update Posted (Actual)

December 29, 2023

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHFudanU_COVID19-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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