US Children's Hospital started HEALthy Brain and Child Development Study - COVID-19 Supplement

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Boston Children's Hospital is conducting the clinical trial HEALthy Brain and Child Development Study - COVID-19 Supplement.

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.

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 determining measures of stress response in relation to a maternal COVID-19 diagnosis and characterize the neurodevelopmental sequelae of those infants born to mothers with a COVID-19 infection.

It is planned to include 75 participants.

Actual study start date is October 5, 2020. The researchers expect to complete the study by November 2021.

Among study population are Infants born to COVID-19-positive and COVID-19-negative women.

Participants will be excluded if the child:

• is born at less than 34 weeks or if birth weight is not appropriate for dates.
• has an identified genetic, metabolic, syndromic or progressive neurological disorder (e.g., Down Syndrome, Rett Syndrome, Tuberous Sclerosis, Neurofibromatosis, Fragile X Syndrome) at birth or within the first year.

The location of the study is as follows (further details can be found here https://ichgcp.net/clinical-trials-registry/NCT04713150) Boston, United States; Boston, United States; Boston, United States.