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:
Organization:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study Design
Study Type:
OBSERVATIONAL
Expanded Access Type Individual:
None
Expanded Access Type Intermediate:
None
Expanded Access Type Treatment:
None
Patient Registry:
True
Target Duration:
12 Months
Design Allocation:
Design Intervention Model:
Design Intervention Model Description:
Design Masking Description:
Bio Spec Retention:
SAMPLES_WITHOUT_DNA
Bio Spec Description:
A group of newborns of mothers infected by sars-cov-2 will present biological markers suggestive of presenting an abnormal inflammatory state inflammation signature that puts them at risk of suffering neurodevelopmental alterations Inflammatory alterations in NBs will be related to clinical variables such as the time gestational age of maternal infection and its severity and based on previous literature alterations in the innate immune response will be associated with the clinical phenotype of the newborn This is the cohort C N100 infected and non-infected
Enrollment Count:
1000
Enrollment Type:
ESTIMATED
Design Primary Purpose:
Design Masking:
Phases:
Observational Models:
| Name |
|---|
| Cohort |
Time Perspective List:
Clinical Trial Statuses
| Name |
|---|
| 105986 |
Who Masked List: