HEALthy Brain and Child Development Study - COVID-19 Supplement

Covid19 Clinical Trial

Official title:

HEALthy Brain and Child Development Study - COVID-19 Supplement

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04713150
• Other study ID #: P00035929
• Status: Active, not recruiting
• Start date: October 5, 2020
• Est. completion date: November 2023

Study information

• Verified date: September 2023
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: November 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Child Development
• COVID-19
• Covid19
• Prenatal Infection
• Prenatal Stress

Intervention

Other:
• No Intervention
No Intervention

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	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	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston Children's Hospital	Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal stress associated with a SARS-CoV-2 diagnosis in pregnancy.	Using the Perceived Stress Scale (scores can range from 0 to 40, with higher scores indicating greater stress).	9 months (Third trimester - 6 month postnatal visit)
Primary	Maternal mental health associated with a SARS-CoV-2 diagnosis in pregnancy.	Using the Edinburgh Postnatal Depression Scale (scores range from 0-30, with higher scores indicating greater feelings of depression).	30 months (Third trimester - 24 month postnatal visit)
Primary	Inventory of maternal experience associated with a SARS-CoV-2 diagnosis in pregnancy.	Using the Recent Life Events Questionnaire (indexes 30 common life events that encompass both positive and negative events).	30 months (Third trimester - 24 month postnatal visit)
Primary	Inventory of maternal experience related to healthcare associated with a SARS-CoV-2 diagnosis in pregnancy.	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).	30 months (Third trimester - 24 month postnatal visit)
Primary	Global cognitive ability of offspring	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.	3 months, 6 months, 9 months, 12 months, and 24 months
Primary	Neural networks of offspring	Using Electroencephalography at 3 months and 6 months postnatally	3 months, 6 months, 9 months, 12 months, and 24 months
Primary	Early structural and functional brain development of offspring	Using MRI imaging, which will be obtained at 1-2 days of life	1-2 days of life and/or 3-9 months of life