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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05379452

Enrollment

236

Registered

2022-05-18

Start date

2022-03-01

Completion date

2023-01-01

Last updated

2023-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Infection, Outcomes, SARS-CoV2 Infection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 28 Days

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Parents who rejected to participate in this study.

Design outcomes

Primary

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

Secondary

Measure	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
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

Countries

China

Outcome results