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

NCT06968897 | Enrolling By Invitation

• 1 other identifier: AZ 114/22
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SARS CoV-2; Developmental Disorder; Pregnancy Related

Keywords

SARS-CoV-2; Children; Development; pregnancy

Outcome Measures

Primary Outcomes (1)

• Motoric skills

  Motoric skills will be measured using the M-ABC-2 ("global rate"), as well as parental self reports in the ASQ-3 (areas: "gross motor" and "fine motor") with age-specific cut-off values.

  36 to 60 months old children

Secondary Outcomes (2)

• Communication

  36 to 60 months old children

• Personal-Social development

  36 to 60 months old children

Study Arms (2)

Exposed intrauterine to SARS-CoV-2

Toddlers exposed to SARS-CoV-2 (VOC alpha or delta) during their mothers' pregnancy.

Not exposed to SARS-CoV-2

Toddlers NOT exposed to SARS-CoV-2 (VOC alpha or delta) during their mothers' pregnancy.

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

In a pilot study intrauterine exposed toddlers are eligible for inclusion in the study if their mothers are registered in the CRONOS registry in the following five university hospitals: Marburg University Hospital, Jena University Hospital, Kiel University Hospital, Dresden University Hospital and Freiburg University Hospital. Controls, i.e. infants who have not been exposed to SARS-CoV-2, are eligible for enrolment if they live in the proximity of the recruiting hospitals.

You may qualify if:

• Toddlers (age 33 to 60 months), who were exposed (case) or not exposed (controll) with SARS-CoV-2 intrauterin.

You may not qualify if:

• No parental consent

Sponsors & Collaborators

• Philipps University Marburg: lead

Study Sites (1)

Philipps University of Marburg

Marburg, 35037, Germany

Location

Related Publications (1)

• Pecks U, Mand N, Kolben T, Rudiger M, Oppelt P, Zollkau J, Dempfle A; The CRONOS registry. SARS-CoV-2 Infection During Pregnancy-An Analysis of Clinical Data From Germany and Austria From the CRONOS Registry. Dtsch Arztebl Int. 2022 Sep 5;119(35-36):588-594. doi: 10.3238/arztebl.m2022.0266.

  PMID: 35794736 BACKGROUND

Related Links

• This website has been created with the express purpose of providing patients with information regarding the study.

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Nadine Mand

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 13, 2025
• Study Start: April 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)