An observational study in Child Development, Prenatal Infection and Prenatal Stress, sponsored by Boston Children's Hospital. Completed at 4 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Boston Children's Hospital · Observational
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:
7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 62 is below the median of 260 across 3,135 observational studies indexed under COVID-19.
Browse COVID-19 studies →Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
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Infants born to COVID-19-positive and COVID-19-negative women.
Exclusion Criteria:
Participants will be excluded if the child:
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.
Other: No Intervention
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.
Other: No Intervention
No Intervention
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 3 months, 6 months, 9 months, 12 months, and 24 months
Neural networks of offspring
Using Electroencephalography at 3 months and 6 months postnatally
Time frame: 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
Time frame: 1-2 days of life and/or 3-9 months of life
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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