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NCT06968897: CRONOS-Kids

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

ENROLLING BY INVITATION Last updated 13 May 2025
What this trial tests

trial in SARS CoV-2 in 250 participants. Enrolling by invitation.

Timeline
1 April 2025
Primary endpoint
31 December 2025
30 June 2026

Quick facts

Lead sponsorPhilipps University Marburg
StatusENROLLING BY INVITATION
Study typeOBSERVATIONAL
Enrollment250
Start date1 April 2025
Primary completion31 December 2025
Estimated completion30 June 2026
Sites1 location across Germany

Conditions studied

Sponsor

Philipps University Marburg

Who can join

Adults 3 to 5, any sex, with SARS CoV-2 or Developmental Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. From CRONOS to CRONOS-Kids: Investigating Neurological Development in Toddlers After Maternal SARS-CoV-2 Infection During Pregnancy – A Study Protocol For A Prospective Cohort Study
    Mand N, König F, Wege M, Cares A, et al · · 2025 · DOI 10.21203/rs.3.rs-8295431/v1

Verify or expand the search:

Other recruiting trials for SARS CoV-2

Currently open trials in the same condition.

Other Philipps University Marburg trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06968897.

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