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HEALthy Brain and Child Development Study - COVID-19 Supplement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04713150
Recruitment Status : Recruiting
First Posted : January 19, 2021
Last Update Posted : November 14, 2022
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Charles Alexander Nelson III, Boston Children's Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Child Development Prenatal Infection Prenatal Stress Covid19 Other: No Intervention

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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
No Intervention


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

  6. 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

  7. 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


Eligibility Criteria
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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
Study Population
Infants born to COVID-19-positive and COVID-19-negative women.
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Charles Nelson, PhD 617 355-0400 familiesHEAL@childrens.harvard.edu
Contact: Erin Carmody 8572183011 familiesHEAL@childrens.harvard.edu

Locations
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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       kgray6@bwh.harvard.edu   
Contact: Kirsten Thiim       kthiim@bwh.harvard.edu   
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       abcastil@bidmc.harvard.edu   
Sponsors and Collaborators
Boston Children's Hospital
Brigham and Women's Hospital
Massachusetts General Hospital
Investigators
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Principal Investigator: Charles A Nelson, PhD Boston Children's Hospital
More Information
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Responsible Party: Charles Alexander Nelson III, Principle Investigator, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT04713150    
Other Study ID Numbers: P00035929
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases