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NCT05430594 Clinical Trial

This Study Investigate the Impact of Maternal COVID-19 Infection During Birth on the Childrens' Physical and Mental Development.

COVID-19 Clinical Trial

— Coronababies  

Official title:
Long-term Followup of Children Was Born From COVID Positive Mother During Birth

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05430594
Other study ID # SE RKEB: 14/2022.
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2, 2022
Est. completion date June 30, 2024

Study information
Verified date June 2022
Source Semmelweis University
Contact Fanni Toth, Dr
Phone +36306924507
Email toth.fanni2@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study investigates the impact of the maternal COVID infection during birth on the children's development: physical and mental outcomes. We would like to differentiate the effect from the viral infection and effect of the pandemic period, too.

Recruitment information / eligibility
Status Recruiting
Enrollment 130
Est. completion date June 30, 2024
Est. primary completion date July 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months to 16 Months
Eligibility Inclusion Criteria: - postitive maternal COVID test during the birth - the newborn was cared at the Semmelweis University after birth

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Hungary Semmelweis University, Department of Obstetrics and Gynecology Budapest

Sponsors (1)
Lead Sponsor Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome
Type Measure Description Time frame Safety issue
Primary Neurodevelopmental outcome 2 years old
Secondary Neurodevelopmental outcome 1 year old
Secondary Phsycosomatic outcome 1 and 2 years old
Secondary Regulation disorders 1 and 2 years old
Secondary Feeding 1 and 2 years old
Secondary Maternal mental status 1 and 2 years old
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