HEALthy Brain and Child Development Study - COVID-19 Supplement

Boston Children's Hospital

Status: Active, not recruiting

Conditions: Child Development; Prenatal Stress; Covid19; Prenatal Infection

Treatments: Other: No Intervention

Study type: Observational

Funder types: Other

Identifiers

NCT04713150

P00035929

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• English or Spanish- speaking of any ethnicity
• Women, aged 18 or older
• Women who received COVID-19 diagnoses during pregnancy OR Women without any SARS-CoV-2 positive test during pregnancy, any suspected COVID illness (even if not tested) or who received a negative COVID-19 test result during pregnancy

Exclusion criteria

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

Trial design

75 participants in 2 patient groups

COVID-19 Positive During Pregnancy

Description:

Sixty mother-child dyads, who have or had a confirmed positive COVID-19 test during pregnancy, will be recruited and enrolled in this study. All women enrolled must be 18 years of age or older. Her child will go on to participate at 2-5 days of age, and again at 3-, 6-, 9-, 12- and 24-months of age.

Treatment:

Other: No Intervention

COVID-19 Negative During Pregnancy

Description:

Twenty-five mother-child dyads, who have a confirmed negative COVID-19 test during pregnancy will be recruited and enrolled in the study. Women without any SARS-CoV-2 positive test during pregnancy or any suspected COVID illness, even if not tested, will be enrolled. All women enrolled must be 18 years of age or older. Her child will go on to participate at 3-, 6-, 9-, 12- and 24-months of age.

Treatment:

Other: No Intervention