NCT05379452

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

10 months

First QC Date

May 16, 2022

Last Update Submit

December 27, 2023

Conditions

SARS-CoV2 InfectionNeonatal InfectionOutcomes

Outcome Measures

Primary Outcomes (1)

  • The death of newborns

    The date of discharge，an average of 4 weeks after the admission

Secondary Outcomes (5)

  • The malformation rate of neonates born to mothers with SARS-CoV-2 infections

    Birth

  • The preterm delivery 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 development delay rate of neonates born to mothers with SARS-CoV-2 infections

    within 1 year after the admission

  • 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

AgeUp to 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Parents who rejected to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children Hospital of Fudan University

Shanghai, 201102, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2022

First Posted

May 18, 2022

Study Start

March 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

December 29, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Locations

CN(1)