Clinical Trials Directory

Trials / Completed

CompletedNCT04713150

HEALthy Brain and Child Development Study - COVID-19 Supplement

Status
Completed
Phase
Study type
Observational
Enrollment
62 (actual)
Sponsor
Boston Children's Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to advance the scientific understanding of how a prenatal COVID-19 infection and associated psychological distress influences infant neurodevelopment. This project will aim to shed light on how families and child development are impacted by the current COVID-19 pandemic and will work to better support these families and children as they grow.

Detailed description

Prenatal exposure to maternal illness and stress has been widely associated with adverse neurodevelopmental outcomes, including deficits in cognition and socioemotional development. The principal goal of this project utilizes Magnetic Resonance Imaging (MRI), Electroencephalography (EEG), and a variety of behavioral measures to assess brain maturation and neurodevelopment among infants exposed prenatally to COVID-19 and associated high levels of stress. The planned experiments are effective in identifying brain markers that may contribute to resiliency in young infants, determining measures of stress response in relation to a maternal COVID-19 diagnosis, and characterizing the neurodevelopment of those infants born to mothers with a COVID-19 infection. Specific goals include: 1. To determine the prevalence of psychological distress in pregnant women with a confirmed COVID-19 diagnosis and to examine the extent to which existing high risk environments play a role in the susceptibility of heightened psychological distress. 2. To examine the effects of prenatal distress and maternal illness/inflammation related to a maternal COVID-19 diagnosis on early structural and functional brain development. 3. To characterize neural networks that may have been impacted by a maternal COVID-19 infection and related stress during pregnancy. 4. To assess the early neurodevelopment outcomes of infants exposed to elevated prenatal stress related to a maternal COVID-19 diagnosis during pregnancy.

Conditions

Interventions

TypeNameDescription
OTHERNo InterventionNo Intervention

Timeline

Start date
2020-10-05
Primary completion
2023-09-14
Completion
2023-09-14
First posted
2021-01-19
Last updated
2026-04-06

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT04713150. Inclusion in this directory is not an endorsement.