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Principal Investigator: PINGSHENG WU
Organization: VANDERBILT UNIVERSITY MEDICAL CENTER
Fiscal Year: 2024
Award: $246,832
Funding agency: National Institute of Allergy and Infectious Diseases
PROJECT SUMMARY/ABSTRACT:
This application is being submitted to PA-20-272 in accordance with NOT-OD-22-137. We propose to
leverage the infrastructure of the parent study (R01 AI143710), a large population-based birth cohort of over
3,000 individuals with Down syndrome (DS), an experienced study team, to study all-cause respiratory
morbidity during the pandemic time of individuals with DS. This application is eligible for the Administrative
Supplement award as it proposes to address “Component 2: Assembly of a large cohort of individuals with
Down syndrome across the lifespan to perform deep phenotyping and study co-existing conditions” of the
INLCUDE project (Investigation of Co-occurring conditions across the Lifespan to Understand Down
syndromE). Individuals with DS will be followed through 2023 to study the respiratory burden during the
pandemic, a priority of National Institute of Allergy and Infectious Diseases (NIAID) for the INCLUDE project.
The underlying immunologic, anatomic, and physiologic abnormalities of DS make individuals with DS
susceptible to respiratory viral infections and less responsive to immunizations. During the pandemic, studies
have shown that individuals with DS are at increased risk of severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) infections and more severe SARS-CoV-2 infections. On the other hand, the implementation of
non-pharmaceutical interventions (NPIs) such as hand washing, social distancing, and face masking has
resulted a dramatic global reduction in the incidence of common respiratory virus infections during the
pandemic. Respiratory burden resulting from these viruses in individuals with DS might be reduced. The
overarching objectives of the study are to determine the burden of respiratory morbidity in individuals
with DS during the pandemic time. Building upon the parent study of a population-based birth cohort of
3,051 children with DS who were born in 1995-2019 and enrolled in Tennessee Medicaid Program and
Department of Defense Military Healthcare System, we propose to 1) expand the cohort to include individuals
with DS who were born during the pandemic (born 2020-2023, estimated N=705) and 2) extend the follow-up
period of the current subjects (born 1995-2019) to 2023 to study all-cause respiratory morbidity during the
pandemic time. We will determine the rates and quantify the severity of COVID-19 related and unrelated
respiratory healthcare encounters. Respiratory morbidity, including healthcare encounters for COVID-19,
pneumonia, otitis media, croup, wheezing, asthma, bronchitis, bronchiolitis, respiratory failure, tympanostomy
tube, and other respiratory related morbidity, will be examined.
Public Health Impact. Results of the study will provide a better understanding of the overall prevalence and
burden of COVID-19 related and unrelated respiratory morbidity, and provide important information to inform
the usage of subsequent vaccines, protection products, and therapeutic strategies in individuals with DS, an
important goal of the INCLUDE project and part of our research team’s long-term interest.
Terms: <0-11 years old><2019 novel corona virus><2019 novel coronavirus><2019-nCoV><6 year old><6 years of age><Active Follow-up><Acute Obstructive Laryngitis><Adaptive Immune System><Address><Administrative Supplement><Age><Airway failure><Airway health><Airway infections><Anatomic Abnormality><Anatomic Sites><Anatomic structures><Anatomical Abnormality><Anatomy><Antibody Response><Armed Forces Personnel><Aspiration of middle ear><Asthma><Award><Birth><Bronchial Asthma><Bronchiolitis><Bronchitis><COVID burden><COVID crisis><COVID disease severity><COVID epidemic><COVID pandemic><COVID severity><COVID-19><COVID-19 affected><COVID-19 burden><COVID-19 consequence><COVID-19 crisis><COVID-19 disease burden><COVID-19 disease severity><COVID-19 effect><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health burden><COVID-19 health crisis><COVID-19 impact><COVID-19 impacted><COVID-19 infection><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 related burden><COVID-19 severity><COVID-19 vaccination><COVID-19 virus><COVID-19 virus infection><COVID-19 years><COVID19 disease severity><COVID19 infection><COVID19 severity><COVID19 virus><CV-19><Calendar><Cardiac Malformation><Cessation of life><Characteristics><Child><Child Youth><Children (0-21)><Chromosomal Disorders><Chromosome 21><Chromosome Abnormality Disorders><Chromosome Disorders><Clinical><CoV-2><CoV2><Code><Coding System><Complication><Congenital chromosomal disease><Coronavirus Infectious Disease 2019><Croup><Data><Death><Deformity><Department of Defense><Down's Syndrome><Drugs><Eligibility><Eligibility Determination><Enrollment><Face><Future><Goals><Grippe><Handwashing><Health Care Systems><Healthcare><Healthcare Systems><Heart Malformation><Immunization><Immunochemical Immunologic><Immunologic><Immunological><Immunologically><Immunologics><Incidence><Individual><Infant><Infection><Influenza><Infrastructure><Innate Immune System><Inpatients><Intervention><Intervention Strategies><Investigation><Langdon Down syndrome><Lung><Lung Respiratory System><Mechanical ventilation><Medicaid><Medication><Middle ear paracentesis><Military><Military Personnel><Mongolism><Morbidity><Morbidity - disease rate><Myringostomy><Myringotomy><NIAID><National Institute of Allergy and Infectious Disease><O element><O2 element><Organ><Otitis Media><Out-patients><Outpatients><Oxygen><Paracentesis of tympanum><Parents><Parturition><Persons><Pharmaceutical Preparations><Phenotype><Physical distancing><Physiologic><Physiological><Pneumonia><Predisposition><Prevalence><Protocol Screening><Public Health><Recurrence><Recurrent><Reporting><Research><Respiratory Failure><Respiratory Infections><Respiratory Tract Infections><Respiratory syncytial virus><Risk><Risk Factors><SARS corona virus 2><SARS-CO-V2><SARS-COVID-2><SARS-CoV-2><SARS-CoV-2 burden><SARS-CoV-2 disease burden><SARS-CoV-2 disease severity><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 infection><SARS-CoV-2 infection burden><SARS-CoV-2 pandemic><SARS-CoV-2 severity><SARS-CoV-2 vaccination><SARS-CoV2><SARS-CoV2 infection><SARS-associated corona virus 2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><SARS-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><Severe Acute Respiratory Coronavirus 2><Severe Acute Respiratory Distress Syndrome CoV 2><Severe Acute Respiratory Distress Syndrome Corona Virus 2><Severe Acute Respiratory Distress Syndrome Coronavirus 2><Severe Acute Respiratory Syndrome CoV 2><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe Acute Respiratory Syndrome-associated coronavirus 2><Severe Acute Respiratory Syndrome-related coronavirus 2><Severe acute respiratory syndrome associated corona virus 2><Severe acute respiratory syndrome coronavirus 2><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 infection><Severe acute respiratory syndrome coronavirus 2 pandemic><Severe acute respiratory syndrome coronavirus 2 vaccination><Severe acute respiratory syndrome related corona virus 2><Severities><Severity of illness><Sleep Apnea><Sleep Apnea Syndromes><Sleep Hypopnea><Sleep-Disordered Breathing><Social Distance><Subgroup><Susceptibility><Tennessee><Therapeutic><Time><Trisomy 21><Tube><Tympanocentesis><Tympanostomy><Tympanotomy><United States><Vaccination><Vaccines><Variant><Variation><Viral Respiratory Tract Infection><Virus><Visit><Wheezing><World Health Organization><Wuhan coronavirus><abnormal heart development><acquired immune system><active followup><age 6 years><ages><airway morbidity><chromosome 21 trisomy syndrome><cohort><congenital acromicria syndrome><congenital cardiac abnormality><congenital cardiac anomalies><congenital cardiac disease><congenital cardiac disorder><congenital cardiac malformation><congenital heart abnormality><congenital heart anomaly><congenital heart disease><congenital heart disorder><congenital heart malformation><coronavirus disease 2019><coronavirus disease 2019 consequence><coronavirus disease 2019 crisis><coronavirus disease 2019 disease severity><coronavirus disease 2019 effect><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 impact><coronavirus disease 2019 infection><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease 2019 severity><coronavirus disease 2019 vaccination><coronavirus disease 2019 virus><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease severity><coronavirus disease-19><coronavirus disease-19 global pandemic><coronavirus disease-19 impact><coronavirus disease-19 pandemic><coronavirus disease-19 virus><coronavirus infectious disease-19><disease severity><drug/agent><enroll><experience><faces><facial><follow up><follow-up><followed up><followup><hCoV19><hand washing><health care><infected with COVID-19><infected with COVID19><infected with SARS-CoV-2><infected with SARS-CoV2><infected with coronavirus disease 2019><infected with severe acute respiratory syndrome coronavirus 2><interest><interventional strategy><kids><life span><life-threatening COVID><life-threatening COVID-19><life-threatening SARS-CoV-2><life-threatening coronavirus disease><life-threatening coronavirus disease 2019><life-threatening severe acute respiratory syndrome coronavirus 2><lifespan><mechanical respiratory assist><mechanically ventilated><middle ear infection><military population><morbus Down><mortality><nCoV2><pandemic><pandemic disease><parent><population based><programs><pseudohypertrophic progressive muscular dystrophy><pulmonary><respiratory><respiratory health><respiratory infection virus><respiratory morbidity><respiratory virus><serious COVID><serious COVID-19><serious SARS-CoV-2><serious coronavirus disease><serious coronavirus disease 2019><serious severe acute respiratory syndrome coronavirus 2><severe COVID><severe COVID-19><severe COVID19><severe SARS-CoV-2><severe acute respiratory syndrome coronavirus 2 disease severity><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><severe acute respiratory syndrome coronavirus 2 severity><severe coronavirus disease><severe coronavirus disease 19><severe coronavirus disease 2019><severe severe acute respiratory syndrome coronavirus 2><six year old><six years of age><sleep-related breathing disorder><trisomy 21 syndrome><vaccinate against COVID-19><vaccinate against SARS-CoV-2><vaccinate against coronavirus disease 2019><vaccinate against severe acute respiratory syndrome coronavirus 2><vaccination against COVID-19><vaccination against SARS-CoV-2><vaccination against Severe acute respiratory syndrome coronavirus 2><vaccination against coronavirus disease 2019><viral respiratory infection><wheeze><youngster>