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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19 and Pregnancy
• Intervention / Treatment: Other: Severity of infection, time of infection.; Other: Mental health assessment; Other: biological

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• Spain
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.; Severity of infection, time of infection.
Cohort B N=500; Mental health assessment	Other: Mental health assessment; Mental health assessment
Cohort C N=100; biological	Other: biological; Prognostic immunologic factors associated with cognitive impairment in children born of sars-cov-2-infected mothers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): August 1, 2023
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: SIGNATURE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No