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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Massachusetts General Hospital | OTHER |
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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 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 Positive During Pregnancy | 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. |
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| COVID-19 Negative During Pregnancy | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | No Intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Maternal stress associated with a SARS-CoV-2 diagnosis in pregnancy. | Using the Perceived Stress Scale (scores can range from 0 to 40, with higher scores indicating greater stress). | 9 months (Third trimester - 6 month postnatal visit) |
| Maternal mental health associated with a SARS-CoV-2 diagnosis in pregnancy. | Using the Edinburgh Postnatal Depression Scale (scores range from 0-30, with higher scores indicating greater feelings of depression). | 30 months (Third trimester - 24 month postnatal visit) |
| Inventory of maternal experience associated with a SARS-CoV-2 diagnosis in pregnancy. | Using the Recent Life Events Questionnaire (indexes 30 common life events that encompass both positive and negative events). | 30 months (Third trimester - 24 month postnatal visit) |
| Inventory of maternal experience related to healthcare associated with a SARS-CoV-2 diagnosis in pregnancy. | Using the COPE Survey (50-item inventory of experiences for new or expectant mothers during the COVID-19 pandemic; psychometric properties and scoring procedures for this measure have yet to be determined). | 30 months (Third trimester - 24 month postnatal visit) |
| Global cognitive ability of offspring | Using the Mullen Scales of Early Learning at 3 months and 6 months postnatally. Five skill areas are measured: Gross Motor and four cognitive skills. These cognitive skill are summarized into an Early Learning Composite (scores are permitted to range from 20 to 80) - Fine Motor, Visual Reception, Receptive Language, and Expressive Language. The raw scores for each scale can be converted into age-adjusted normalized scores. | 3 months, 6 months, 9 months, 12 months, and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
Participants will be excluded if the child:
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Infants born to COVID-19-positive and COVID-19-negative women.
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| Name | Affiliation | Role |
|---|---|---|
| Charles A Nelson, PhD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Brigham and Women's Hospital |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Neural networks of offspring | Using Electroencephalography at 3 months and 6 months postnatally | 3 months, 6 months, 9 months, 12 months, and 24 months |
| Early structural and functional brain development of offspring | Using MRI imaging, which will be obtained at 1-2 days of life | 1-2 days of life and/or 3-9 months of life |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Laboratories of Cognitive Neuroscience, Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |