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ENROLLING BY INVITATION
NCT06968897

Neurological Development In Toddlers After Maternal SARS-CoV-2 Infection During Pregnancy

Sponsor: Philipps University Marburg

View on ClinicalTrials.gov

Summary

Severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) is a virus that causes neurological symptoms in a significant proportion of patients in addition to respiratory symptoms. Intrauterine exposure to the virus has been demonstrated to exert a detrimental effect on the developing nervous system. However, developmental disorders frequently remain undetected until late infancy or early childhood. Consequently, there is a paucity of published data on neurodevelopment in young children following SARS-CoV-2 infection of their pregnant mothers. To this end, detailed data from children aged 36-60 months exposed to SARS-CoV-2 in utero will be compared with unexposed children of the same age on several clinical outcome parameters. Data in this cohort study will be adjusted for possible confounding variables, such as gestational age at birth, sex, or umbilical arterial pH, in order to investigate a relative risk of intrauterine SARS-CoV-2 infection on clinical outcomes, such as child development. Furthermore, the potential protective effect of SARS-CoV-2 vaccination during pregnancy will be investigated. This study will provide significant data on the clinical outcomes of children exposed perinatally to SARS-CoV-2. The findings will enable healthcare providers to establish a risk score-adapted follow-up strategy for the general paediatric population of infants.

Official title: Neurological Development in Toddlers After Maternal SARS-CoV-2 Infection During Pregnancy - A Follow-Up to the Covid-19 Related Obstetric and Neonatal Outcome Study in Germany (CRONOS) With a Dedicated Focus on Child Health

Key Details

Gender

All

Age Range

3 Years - 5 Years

Study Type

OBSERVATIONAL

Enrollment

250

Start Date

2025-04-01

Completion Date

2026-06-30

Last Updated

2025-05-13

Healthy Volunteers

Yes

Locations (1)

Philipps University of Marburg

Marburg, Germany