HEALthy Brain and Child Development Study - COVID-19 Supplement

NCT04713150 | Unknown

• 1 other identifier: P00035929
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 4

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.

Conditions

Child Development; Prenatal Infection; Prenatal Stress; Covid19

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

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

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

Interventions

No Intervention OTHER

No Intervention

COVID-19 Negative During Pregnancy; COVID-19 Positive During Pregnancy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Brigham and Women's Hospital: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Laboratories of Cognitive Neuroscience, Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Charles A Nelson, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: January 19, 2021
• Study Start: October 5, 2020
• Primary Completion: September 1, 2023
• Study Completion: November 1, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

US (4)