HEALthy Brain and Child Development Study - COVID-19 Supplement
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|ClinicalTrials.gov Identifier: NCT04713150|
Recruitment Status : Recruiting
First Posted : January 19, 2021
Last Update Posted : November 14, 2022
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|Condition or disease||Intervention/treatment|
|Child Development Prenatal Infection Prenatal Stress Covid19||Other: No Intervention|
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:
- 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.
- 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.
- To characterize neural networks that may have been impacted by a maternal COVID-19 infection and related stress during pregnancy.
- To assess the early neurodevelopment outcomes of infants exposed to elevated prenatal stress related to a maternal COVID-19 diagnosis during pregnancy.
|Study Type :||Observational|
|Estimated Enrollment :||75 participants|
|Official Title:||HEALthy Brain and Child Development Study - COVID-19 Supplement|
|Actual Study Start Date :||October 5, 2020|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||November 2023|
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.
Other: No Intervention
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.
Other: No Intervention
- Maternal stress associated with a SARS-CoV-2 diagnosis in pregnancy. [ Time Frame: 9 months (Third trimester - 6 month postnatal visit) ]Using the Perceived Stress Scale (scores can range from 0 to 40, with higher scores indicating greater stress).
- Maternal mental health associated with a SARS-CoV-2 diagnosis in pregnancy. [ Time Frame: 30 months (Third trimester - 24 month postnatal visit) ]Using the Edinburgh Postnatal Depression Scale (scores range from 0-30, with higher scores indicating greater feelings of depression).
- Inventory of maternal experience associated with a SARS-CoV-2 diagnosis in pregnancy. [ Time Frame: 30 months (Third trimester - 24 month postnatal visit) ]Using the Recent Life Events Questionnaire (indexes 30 common life events that encompass both positive and negative events).
- Inventory of maternal experience related to healthcare associated with a SARS-CoV-2 diagnosis in pregnancy. [ Time Frame: 30 months (Third trimester - 24 month postnatal visit) ]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).
- Global cognitive ability of offspring [ Time Frame: 3 months, 6 months, 9 months, 12 months, and 24 months ]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.
- Neural networks of offspring [ Time Frame: 3 months, 6 months, 9 months, 12 months, and 24 months ]Using Electroencephalography at 3 months and 6 months postnatally
- Early structural and functional brain development of offspring [ Time Frame: 1-2 days of life and/or 3-9 months of life ]Using MRI imaging, which will be obtained at 1-2 days of life
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- 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
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04713150
|Contact: Charles Nelson, PhD||617 355-0400||familiesHEAL@childrens.harvard.edu|
|Contact: Erin Carmody||8572183011||familiesHEAL@childrens.harvard.edu|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Andrea Edlow, MD, MSc AEDLOW@MGH.HARVARD.EDU|
|Contact: Cordelia Muir CMUIR2@mgh.harvard.edu|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Elizabeth Singh email@example.com|
|Contact: Kirsten Thiim firstname.lastname@example.org|
|Sub-Investigator: Kathryn Gray, MD|
|Sub-Investigator: Terrie Inder, MBChB|
|Laboratories of Cognitive Neuroscience, Boston Children's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Erin Carmody 857-218-3011 familiesHEAL@childrens.harvard.edu|
|Principal Investigator: Charles A Nelson, PhD|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Alejandra Barrero-Castillero, MD, MPH email@example.com|
|Principal Investigator:||Charles A Nelson, PhD||Boston Children's Hospital|
|Responsible Party:||Charles Alexander Nelson III, Principle Investigator, Boston Children's Hospital|
|Other Study ID Numbers:||
|First Posted:||January 19, 2021 Key Record Dates|
|Last Update Posted:||November 14, 2022|
|Last Verified:||November 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases