MedTrace Logo

Stress in Pregnancy During the Covid19 Pandemic and Impact on the Newborn Neurodevelopment

NCT06362486 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2024-04-12

No results posted yet for this study

Summary

The Covid19 pandemic, paradoxically, represents a valuable opportunity to carry out cohort studies that allow us to advance our knowledge about the relationship between inflammation, brain development and an increased risk of suffering from neuropsychiatric disorders or alterations. In addition, the current availability of sophisticated biological techniques and evaluation procedures represents an unique option for this purpose.

Here, we propose a cohort study of sars-cov-2 (type 2 coronavirus causing severe acute respiratory syndrome) infected pregnant women and newborns. We will try to answer the following questions: (i) what is the inflammatory / immune status of newborns (NBs) of mothers infected by Covid19 like?; (ii) is there a relationship between the clinical characteristics of the maternal infection (severity / moment / of infection) and the inflammatory status of the newborn?; (iii) could these features increase the vulnerability to developing central nervous system (CNS) alterations at an early age, and at some point during adult life ?; (iv) How is the Covid19 infected mother's placenta altered? Do the placental alterations Covid19 mediated contribute to develop CNS alterations?; (v) is the infection associated with phenotypes obtained through neurological and neurodevelopmental clinical evaluation (hypotonia, clumsiness, impaired communication and sociability) in children at 6 months and 12 months?

Our main objective is to explore how the presence of stressors and prenatal sars-cov-2 infection generates an abnormal inflammatory activity in the newborn, which is associated with neurodevelopmental disorders and which confers a greater risk of developing neuropsychiatric disorders. The biological information of the umbilical cord (fetus blood) and peripheral blood of the mother obtained after childbirth was provided by the cohort of women during the Covid19 pandemic monitored during their pregnancy, delivery, childbirth and postpartum. These samples and the clinical characterisation of the cohort of mothers and newborns, of which we will be able to do an exhaustive longitudinal follow-up, are tremendously valuable at this time. There is a need to establish new research strategies to understand the pathophysiology of neuropsychiatric diseases, and to discover new molecular and cellular mechanisms involved in the development of the CNS.

Conditions

  • Covid19 and Pregnancy

Interventions

OTHER

Severity of infection, time of infection.

Severity of infection, time of infection.

OTHER

Mental health assessment

Mental health assessment

OTHER

biological

Prognostic immunologic factors associated with cognitive impairment in children born of sars-cov-2-infected mothers.

Sponsors & Collaborators

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2023-08-01
Completion
2024-08-01

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06362486 on ClinicalTrials.gov