Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362486
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-11
Brief Title:
Stress in Pregnancy During the Covid19 Pandemic and Impact on the Newborn Neurodevelopment
Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Organization:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study Overview
Official Title:
Stress in Pregnancy During the Covid19 Pandemic and Impact on the Newborn Neurodevelopment
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mothers 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
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 mothers 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None