Outcomes of Neonates Born to Mothers With SARS-CoV-2 Infe... | NCT05379452

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

NCT05379452

Sponsor

Children's Hospital of Fudan University

Status

Terminated

Last Update Posted

Dec 29, 2023Actual

Enrollment

236Actual

Phase

Not provided

Conditions

SARS-CoV2 Infection
Neonatal Infection
Outcomes

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was concluded as planned upon reaching its predetermined endpoint, which included the completion of data collection and achievement of the necessary sample size for statistical significance.

Expanded Access Info

Start Date

Mar 1, 2022Actual

Primary Completion Date

Jan 1, 2023Actual

Completion Date

Jan 1, 2023Actual

First Submitted Date

May 16, 2022

First Submission Date that Met QC Criteria

May 16, 2022

First Posted Date

May 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 27, 2023

Last Update Posted Date

Dec 29, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

236Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Parents who rejected to participate in this study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

28 Days

Standard Ages

Child

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children Hospital of Fudan University		Shanghai		201102	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided