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.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19; Child Development; Prenatal Stress; Prenatal Infection
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Laboratories of Cognitive Neuroscience, Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Infants born to COVID-19-positive and COVID-19-negative women.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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
Neural networks of offspring	Using Electroencephalography at 3 months and 6 months postnatally	3 months, 6 months, 9 months, 12 months, and 24 months
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

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Massachusetts General Hospital; Brigham and Women's Hospital
• Investigators: Principal Investigator: Charles A Nelson, PhD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Estimated): September 1, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: P00035929

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No