Stress in Pregnancy During the Covid19 Pandemic and Impact on the Newborn Neurodevelopment
NCT ID: NCT06362486
Last Updated: 2024-04-12
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
1000 participants
OBSERVATIONAL
2021-08-01
2024-08-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort A N=1000
neurodevelopment assessment by pediatrician, need to refer to neurodevelopmental assessment by specialized team. m-chat. autism diagnosis.
Severity of infection, time of infection.
Severity of infection, time of infection.
Cohort B N=500
Mental health assessment
Mental health assessment
Mental health assessment
Cohort C N=100
biological
biological
Prognostic immunologic factors associated with cognitive impairment in children born of sars-cov-2-infected mothers.
Interventions
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Severity of infection, time of infection.
Severity of infection, time of infection.
Mental health assessment
Mental health assessment
biological
Prognostic immunologic factors associated with cognitive impairment in children born of sars-cov-2-infected mothers.
Eligibility Criteria
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Inclusion Criteria
* 2\. Ultrasound-confirmed pregnancy
* 3\. infected (past or present) or non-infected with Covid19
Exclusion Criteria
* 2\. other concomitant causes of risk of demonstrated neurodevelopmental disorders
* 3\. presents drug abuse except tobacco during pregnancy
* 4\. under 18 years of age
18 Years
FEMALE
Yes
Sponsors
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Locations
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Hospital Universitario Virgen del Rocío
Seville, , Spain
Countries
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Other Identifiers
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SIGNATURE
Identifier Type: -
Identifier Source: org_study_id
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