HEALthy Brain and Child Development Study - COVID-19 Supplement

Active, not recruiting

• Conditions: Prenatal Infection; Child Development; Prenatal Stress; Covid19

• Registration Number: NCT04713150
• Lead Sponsor: Boston Children's Hospital

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.

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 Timeline

• Study Start: 2020-10-05
• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-19
• Status Verified: 2023-09
• Primary Completion: 2023-09
• Last Update Submitted: 2023-09-19
• Last Update Posted: 2023-09-21
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inventory of maternal experience associated with a SARS-CoV-2 diagnosis in pregnancy.	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).
Early structural and functional brain development of offspring	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
Maternal stress associated with a SARS-CoV-2 diagnosis in pregnancy.	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).
Inventory of maternal experience related to healthcare associated with a SARS-CoV-2 diagnosis in pregnancy.	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	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	3 months, 6 months, 9 months, 12 months, and 24 months	Using Electroencephalography at 3 months and 6 months postnatally
Maternal mental health associated with a SARS-CoV-2 diagnosis in pregnancy.	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).

Trial Locations

Locations (4)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Laboratories of Cognitive Neuroscience, Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States