Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04540029
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2020-09-02
Brief Title:
Measuring Outcomes of Maternal COVID-19-related Prenatal Exposure
Sponsor:
IRCCS National Neurological Institute C Mondino Foundation
Organization:
IRCCS National Neurological Institute C Mondino Foundation
Study Overview
Official Title:
Measuring Outcomes of Maternal COVID-19-related Prenatal Exposure
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
Recruiting
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:
MOM-COPE
Brief Summary:
The rapidly spreading coronavirus Covid-19 pandemic is a major concern worldwide and Italy is at the forefront of this emergency At the present moment the effects on the offspring of Covid-19 disease in pregnant women andor the indirect effect of COVID-19-related prenatal maternal stress are poorly understood Epigenetic mechanisms - and especially DNA methylation - are involved in the embedding of prenatal exposures to large-scale disasters into the epigenome and phenotypic outcomes of the offspring Specific target genes include SLC6A4 NR3C1 OXTR BDNF and FKBP5 The central hypothesis of this project is that the exposure to the COVID-19-related prenatal maternal stress may affect infants outcomes from birth to 12 months partially through increased methylation of target genes involved in stress regulation The main goal is to investigate the association between Covid-19 disease in pregnancy or COVID-19-related PMS in women pregnant during the first 9 months of the year 2020 and the emotional social and cognitive developmental outcomes in their infants from birth to 12 months Additionally the role of target genes methylation in mediating this association will be investigated Mothers and their infants will be enrolled from the delivery units of eleven neonatal facilities located in Northern Italys COVID-19 contagion hotspot One group will be enrolled from April to October 2020 COVID-Exposure Pregnancy CEP a second group will be enrolled from April to October 2021 Non-Exposure Pregnancy NEP Moreover the CEP group will include mothers positive or exposed to COVID-19-related MPS during different trimesters of pregnancy allowing within-group comparisons on developmentally sensitive time windows Within 48 hours from baby delivery saliva samples will be obtained from CEP and NEP newborns immediately stored at -20C and analyzed for epigenetic analyses using Next-Generation Sequencing At 3 and 6 months mothers will be asked to fill-in validated and reliable questionnaires on the emotional and social-behavioral development of their infants At 12 months infants stress regulation and maternal sensitivity will be evaluated through video recording of mother-infant interactions This study will provide unprecedented relevant insights on the biochemical mechanisms underlying the impact of Covid-19 disease and the related PMS on human offsprings developmental outcomes
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