Status:
UNKNOWN
HEALthy Brain and Child Development Study - COVID-19 Supplement
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Child Development
Prenatal Infection
Eligibility:
All Genders
18+ years
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 ai...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 5 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04713150
Start Date
October 5 2020
End Date
November 1 2023
Last Update
September 21 2023
Active Locations (4)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
Laboratories of Cognitive Neuroscience, Boston Children's Hospital
Boston, Massachusetts, United States, 02115
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215