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

Sponsor
Children's Hospital of Fudan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05379452
Collaborator
(none)
1,000
Enrollment
1
Location
16
Anticipated Duration (Months)
62.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Outcomes of Neonates Born to Mothers With SARS-CoV-2 Infection During the Outbreak of Omicron in Shanghai: a Cohort Study.
    Actual Study Start Date :
    Mar 1, 2022
    Anticipated Primary Completion Date :
    Jul 1, 2022
    Anticipated Study Completion Date :
    Jul 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. The death of newborns [The date of discharge，an average of 4 weeks after the admission]

    Secondary Outcome Measures

    1. The malformation rate of neonates born to mothers with SARS-CoV-2 infections [Birth]

    2. The preterm delivery rate of neonates born to mothers with SARS-CoV-2 infections [Birth]

    3. The brain injury rate of neonates born to mothers with SARS-CoV-2 infections [within 7days after the admission]

    4. The development delay rate of neonates born to mothers with SARS-CoV-2 infections [within 1 year after the admission]

    5. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 28 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Neonates born to mothers with SARS-CoV-2 infections.
    Exclusion Criteria:
    • Parents who rejected to participate in this study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children Hospital of Fudan University Shanghai China 201102

    Sponsors and Collaborators

    • Children's Hospital of Fudan University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Hospital of Fudan University
    ClinicalTrials.gov Identifier:
    NCT05379452
    Other Study ID Numbers:
    • CHFudanU_COVID19-2
    First Posted:
    May 18, 2022
    Last Update Posted:
    May 18, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    COVID-19

    Study Results

    No Results Posted as of May 18, 2022