In Utero Exposure to SARS-CoV-2 (COVID-19) and Cardiovascular and Metabolic Endpoints in Early Life

Study Overview
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Brief Summary
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Since its initial outbreak in late 2019, coronavirus disease 2019 (COVID-19) caused by the novel coronavirus SARS-CoV-2 has ravaged the globe, causing illness characterized by inflammation and impaired oxygen levels. As a particularly vulnerable group, pregnant women have had a heightened prevalence and severity of infection. In this context, a new population of children has emerged who were exposed to maternal COVID-19 in the womb. As maternal diseases during pregnancy may impact the health of offspring over the life course, health outcomes among these individuals must be urgently evaluated. In the current study, the investigators will leverage a perinatal biorepository comprised of pregnant women with and without COVID-19 to delineate the metabolic and cardiovascular risk profiles of these offspring. This work stands to benefit the burgeoning population of children exposed to COVID-19 in the womb and to deepen the mechanistic understanding of developmental origins of cardiometabolic disease with respect to maternal infections.

Official Title
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In Utero Exposure to SARS-CoV-2 (COVID-19) and Cardiovascular and Metabolic Endpoints in Early Life

Conditions
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In Utero SARS-CoV-2 Exposure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mother with or without prenatal COVID-19 who was enrolled in the MGH COVID-19 Perinatal Biorepository and her child (9-24 months old) Exclusion Criteria: Child with any history of documented COVID-19 Mother who received the COVID-19 vaccine during pregnancy with her child Significant chronic illness in mother or child judged by the investigator to represent a contraindication to study participation

Ages Eligible for Study
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Minimum Age: 9 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SARS-CoV-2 Exposed Dyads<br>Mothers who had SARS-CoV-2 during pregnancy and their offspring | |
| SARS-CoV-2 Unexposed Dyads<br>Mothers who were not known to have SARS-CoV-2 during pregnancy and their offspring | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aortic pulse-wave velocity |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skinfold thicknesses (subscapular, triceps) |  | Baseline | 
| Weight-for-length z-score |  | Baseline | 
| Systolic and diastolic blood pressure |  | Baseline | 
| Beta index of aortic stiffness using echocardiogram |  | Baseline | 
| Aortic intima-media thickness using echocardiogram |  | Baseline | 
| Urinary angiotensin peptide levels |  | Baseline | 
| Urinary angiotensin converting enzyme (ACE) levels |  | Baseline | 
| Left ventricular mass |  | Baseline | 
| Left ventricular dimensions |  | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic disease, cardiovascular disease