Clinical trial NCT04921241: In Utero Exposure to SARS-CoV-2 (COVID-19) and Cardiovascular and Metabolic Endpoints in Early Life
Official title: In Utero Exposure to SARS-CoV-2 (COVID-19) and Cardiovascular and Metabolic Endpoints in Early Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: In Utero SARS-CoV-2 Exposure
Keywords: metabolic disease
cardiovascular disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 86
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: We are recruiting mothers who had COVID-19 during pregnancy and their offspring (9-24 months old). We are also recruiting mothers who were at risk for but not infected with COVID-19 during pregnancy and their children to serve as controls. Mothers in both arms had been contemporaneously enrolled in the MGH COVID-19 Perinatal Biorepository during pregnancy.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Aortic pulse-wave velocity
timeFrame: Baseline
Secondary outcomes:
measure: Skinfold thicknesses (subscapular, triceps)
timeFrame: Baseline
measure: Weight-for-length z-score
timeFrame: Baseline
measure: Systolic and diastolic blood pressure
timeFrame: Baseline
measure: Beta index of aortic stiffness using echocardiogram
timeFrame: Baseline
measure: Aortic intima-media thickness using echocardiogram
timeFrame: Baseline
measure: Urinary angiotensin peptide levels
timeFrame: Baseline
measure: Urinary angiotensin converting enzyme (ACE) levels
timeFrame: Baseline
measure: Left ventricular mass
timeFrame: Baseline
measure: Left ventricular dimensions
timeFrame: Baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: