Clinical trial NCT04713150: HEALthy Brain and Child Development Study - COVID-19 Supplement
Official title: HEALthy Brain and Child Development Study - COVID-19 Supplement
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Child Development
Prenatal Infection
Prenatal Stress
Covid19
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Massachusetts General Hospital
First posted: 2021-01-19
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants born to COVID-19-positive and COVID-19-negative women.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maternal stress associated with a SARS-CoV-2 diagnosis in pregnancy.
timeFrame: 9 months (Third trimester - 6 month postnatal visit)
measure: Maternal mental health associated with a SARS-CoV-2 diagnosis in pregnancy.
timeFrame: 30 months (Third trimester - 24 month postnatal visit)
measure: Inventory of maternal experience associated with a SARS-CoV-2 diagnosis in pregnancy.
timeFrame: 30 months (Third trimester - 24 month postnatal visit)
measure: Inventory of maternal experience related to healthcare associated with a SARS-CoV-2 diagnosis in pregnancy.
timeFrame: 30 months (Third trimester - 24 month postnatal visit)
measure: Global cognitive ability of offspring
timeFrame: 3 months, 6 months, 9 months, 12 months, and 24 months
measure: Neural networks of offspring
timeFrame: 3 months, 6 months, 9 months, 12 months, and 24 months
measure: Early structural and functional brain development of offspring
timeFrame: 1-2 days of life and/or 3-9 months of life
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Laboratories of Cognitive Neuroscience, Boston Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Charles A Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References: