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

NCT06362486 | Active Not Recruiting DMC

• 1 other identifier: SIGNATURE
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• explore how the presence of stressors and prenatal sars-cov-2 infection generates an abnormal inflammatory activity in the newborn

  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.

  birth, at 6 months and 12 months

Study Arms (3)

Cohort A N=1000

neurodevelopment assessment by pediatrician, need to refer to neurodevelopmental assessment by specialized team. m-chat. autism diagnosis.

Other: Severity of infection, time of infection.

Cohort B N=500

Mental health assessment

Other: Mental health assessment

Cohort C N=100

biological

Other: biological

Interventions

Severity of infection, time of infection. OTHER

Severity of infection, time of infection.

Cohort A N=1000

Mental health assessment OTHER

Mental health assessment

Cohort B N=500

biological OTHER

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

Cohort C N=100

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

pregnant women over 18 years of age, without concomitant diseases that affect the neurodevelopment of the newborn or use of toxic substances. For the data collection of the CASE group, these women must have been or be positive for Covid-19. For the CONTROL group, the pregnant woman must not have been infected by Covid-19.

You may qualify if:

• \. over 18 years old
• \. Ultrasound-confirmed pregnancy
• \. infected (past or present) or non-infected with Covid19

You may not qualify if:

• \. presents alcohol abuse during pregnancy
• \. other concomitant causes of risk of demonstrated neurodevelopmental disorders
• \. presents drug abuse except tobacco during pregnancy
• \. under 18 years of age

Sponsors & Collaborators

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

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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 N=100 (infected and non-infected)

MeSH Terms

Conditions

COVID-19

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 12, 2024
• Study Start: August 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-02

Locations

ES (1)