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Completed

NCT Number: NCT04713150

HEALthy Brain and Child Development Study - COVID-19 Supplement

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.

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Key information

Conditions

Child Development COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral Prenatal Infection Prenatal Stress RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No Intervention

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Brigham and Women's Hospital
  • Massachusetts General Hospital

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 19, 2021
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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