Current Environment:

Alert

ENFit Feeding Tube Adapters

GI Feeding Tube Users: if you do not have ENFit tubes, you may need an adapter to deliver feeds or medications. Contact your pharmacy or home care company.

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

Recruitment Status

Recruiting

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: 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.

Eligibility Criteria

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

Intervention

Intervention Type

Intervention Name

Other

No Intervention

Gender

All

Min Age

18 Years

Max Age

N/A

Download Date

January 26, 2022

Principal Investigator

Charles Alexander Nelson III

Primary Contact Information

Charles Nelson, PhD

617 355-0400

familiesHEAL@childrens.harvard.edu

Erin Carmody

8572183011

familiesHEAL@childrens.harvard.edu

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: