ID

45722

Description

Principal Investigator: Edward E. Walsh, M.D, University of Rochester Medical Center, Rochester, NY, USA MeSH: Respiratory Syncytial Virus Infections,Infant https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001201 A prospective multi-year clinical translational study including three cohorts of term infants experiencing their first Respiratory Syncytial Virus (RSV) season. All infants are less than or equal to nine months of age at study entry. The three subject cohorts represent the full spectrum of RSV disease severity and include a birth cohort, a cohort of infants hospitalized for RSV disease and infants evaluated at ambulatory settings for RSV infection. All infants are followed longitudinally and evaluated at recognition of acute RSV infection and twice during convalescence. Innate and adaptive immune status are comprehensively measured in association with clinical, environmental, viral, and bacteriologic factors. Genome-wide expression is assessed in the nasal airways, and in sorted peripheral blood lymphocytes. The study goal is to Identify host responses to RSV infection and factors associated with severe disease.

Link

dbGaP-study=phs001201

Keywords

Versions (1)
  1. 5/24/23 5/24/23 - Chiara Middel
Copyright Holder

Edward E. Walsh, M.D, University of Rochester Medical Center, Rochester, NY, USA

Uploaded on

May 24, 2023

DOI

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License

Creative Commons BY 4.0
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dbGaP phs001201 ASsessing and Predicting Infant RSV Effects and Severity (AsPIRES) Study

English

Eligibility Criteria

9 forms  
  1. StudyEvent: SEV1
    1. Eligibility Criteria
    2. The subject consent file includes subject ID and consent information.
    3. This data table contains a mapping of study subject IDs to sample IDs. Samples are the final preps submitted for genotyping, sequencing, and/or expression data. For example, if one patient (subject ID) gave one sample, and that sample was processed differently to generate 2 sequencing runs, there would be two rows, both using the same subject ID, but having 2 unique sample IDs.
    4. This subject phenotype table contains subject ID, 12 genes (B2M, CD83, CES1, DNAI2, DNAH5, FOXRED1, GPI, KRT8, OAS1, PPIA, SOCS6, TYROBP) being expressed, and scores tied to gene expression.
    5. This subject phenotype table contains subject ID, delivery method, gestational age, birth weight, breastfeeding, family size, smoke exposure, enrollment season, sex, race, ethnicity, age at enrollment, and derived score for breastfeeding.
    6. This subject phenotype table contains subject ID, and any detected bacteria or virus pathogens including H.influenzae, M.catarrhalis, S.pneumoniae, coronavirus, and rhinovirus.
    7. This sample attribute table contains sample ID, and bacteria taxon including Moraxellaceae, Streptococcaceae, and Pasteurellaceae.
    8. This sample attribute table contains sample ID, body site, analyte type, tumor status, histological type, publication, attribute, sequence number, sample days, presence of bacteria and virus (adenovirus, bocavirus, coronavirus, C. pneumoniae, enterobacteriaceae, Flu A or B, H. influenzae, metapneumovirus, catarrhalis, M. hominis, M. pneumoniae, parechovirus, PIV, rhinovirus, respiratory syncytial virus, S. pneumoniae, and ureaplasma), antibody titer scores of serum (Fa, Ga, Gb, RSV A, RSV B, nasal swab, and nasal wash), and read count.
    9. This subject phenotype table contains subject ID, age at time of visit, presence of symptoms (wheezing, rales, retraction, cyanosis, apnea, lethargy, and poor air movement), maximum respiratory rate, worst saturated oxygen score, length of stay, strain of RSV (Respiratory Syncytial Virus), derived RSV severity score, RSV severity label, and antibiotic use.
Inclusion and exclusion criteria
Description

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
Inclusion criteria: Gestational age >=36 weeks and in good health at birth discharge
Description

Elig.phs001201.v2.p1.1

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0456129
UMLS CUI [1,3]
C0018759
UMLS CUI [1,4]
C0205170
Parent/guardian can provide informed consent
Description

Elig.phs001201.v2.p1.2

Data type

boolean

Alias
UMLS CUI [1,1]
C0023226
UMLS CUI [1,2]
C0085732
UMLS CUI [1,3]
C0021430
Infant will be available for duration of the study
Description

Elig.phs001201.v2.p1.3

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0021270
UMLS CUI [1,3]
C0489652
Acute illness documented to be due to RSV infection (hospital cohort only)
Description

Elig.phs001201.v2.p1.4

Data type

boolean

Alias
UMLS CUI [1,1]
C4061114
UMLS CUI [1,2]
C0035235
Born after the previous May 1st
Description

Elig.phs001201.v2.p1.5

Data type

boolean

Alias
UMLS CUI [1,1]
C0005615
UMLS CUI [1,2]
C0231290
UMLS CUI [1,3]
C0205156
UMLS CUI [1,4]
C2348235
UMLS CUI [1,5]
C0011008
Exclusion criteria: Any infant eligible to receive RSV prophylaxis with Palivizumab
Description

Elig.phs001201.v2.p1.6

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0021270
UMLS CUI [1,3]
C1548635
UMLS CUI [1,4]
C0035235
UMLS CUI [1,5]
C0199176
Presence of underlying neuromuscular disorder (i.e., Down's syndrome, cerebral palsy)
Description

Elig.phs001201.v2.p1.7

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0027868
Immunosuppressive condition (i.e., HIV infection in mother) or use of immunosuppressive medications prior to RSV infection
Description

Elig.phs001201.v2.p1.8

Data type

boolean

Alias
UMLS CUI [1,1]
C4048329
UMLS CUI [1,2]
C0021081
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0035235
Presence of malignancy (i.e., Wilms tumor)
Description

Elig.phs001201.v2.p1.9

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C3854307
Inability to contact for the duration of the study
Description

Elig.phs001201.v2.p1.10

Data type

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0332158
UMLS CUI [1,3]
C0681850
Any other condition deemed to place infant at higher risk for severe RSV infection (i.e., NICU transfer at birth, recurrent aspiration)
Description

Elig.phs001201.v2.p1.11

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C0205082
UMLS CUI [1,5]
C0035235
Infants hospitalized for apnea only (hospital cohort only)
Description

Elig.phs001201.v2.p1.12

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0003578
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Similar models

Eligibility Criteria

9 forms
  1. StudyEvent: SEV1
    1. Eligibility Criteria
    2. The subject consent file includes subject ID and consent information.
    3. This data table contains a mapping of study subject IDs to sample IDs. Samples are the final preps submitted for genotyping, sequencing, and/or expression data. For example, if one patient (subject ID) gave one sample, and that sample was processed differently to generate 2 sequencing runs, there would be two rows, both using the same subject ID, but having 2 unique sample IDs.
    4. This subject phenotype table contains subject ID, 12 genes (B2M, CD83, CES1, DNAI2, DNAH5, FOXRED1, GPI, KRT8, OAS1, PPIA, SOCS6, TYROBP) being expressed, and scores tied to gene expression.
    5. This subject phenotype table contains subject ID, delivery method, gestational age, birth weight, breastfeeding, family size, smoke exposure, enrollment season, sex, race, ethnicity, age at enrollment, and derived score for breastfeeding.
    6. This subject phenotype table contains subject ID, and any detected bacteria or virus pathogens including H.influenzae, M.catarrhalis, S.pneumoniae, coronavirus, and rhinovirus.
    7. This sample attribute table contains sample ID, and bacteria taxon including Moraxellaceae, Streptococcaceae, and Pasteurellaceae.
    8. This sample attribute table contains sample ID, body site, analyte type, tumor status, histological type, publication, attribute, sequence number, sample days, presence of bacteria and virus (adenovirus, bocavirus, coronavirus, C. pneumoniae, enterobacteriaceae, Flu A or B, H. influenzae, metapneumovirus, catarrhalis, M. hominis, M. pneumoniae, parechovirus, PIV, rhinovirus, respiratory syncytial virus, S. pneumoniae, and ureaplasma), antibody titer scores of serum (Fa, Ga, Gb, RSV A, RSV B, nasal swab, and nasal wash), and read count.
    9. This subject phenotype table contains subject ID, age at time of visit, presence of symptoms (wheezing, rales, retraction, cyanosis, apnea, lethargy, and poor air movement), maximum respiratory rate, worst saturated oxygen score, length of stay, strain of RSV (Respiratory Syncytial Virus), derived RSV severity score, RSV severity label, and antibiotic use.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Elig.phs001201.v2.p1.1
Item
Inclusion criteria: Gestational age >=36 weeks and in good health at birth discharge
boolean
C1512693 (UMLS CUI [1,1])
C0456129 (UMLS CUI [1,2])
C0018759 (UMLS CUI [1,3])
C0205170 (UMLS CUI [1,4])
Elig.phs001201.v2.p1.2
Item
Parent/guardian can provide informed consent
boolean
C0023226 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Elig.phs001201.v2.p1.3
Item
Infant will be available for duration of the study
boolean
C0470187 (UMLS CUI [1,1])
C0021270 (UMLS CUI [1,2])
C0489652 (UMLS CUI [1,3])
Elig.phs001201.v2.p1.4
Item
Acute illness documented to be due to RSV infection (hospital cohort only)
boolean
C4061114 (UMLS CUI [1,1])
C0035235 (UMLS CUI [1,2])
Elig.phs001201.v2.p1.5
Item
Born after the previous May 1st
boolean
C0005615 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
Elig.phs001201.v2.p1.6
Item
Exclusion criteria: Any infant eligible to receive RSV prophylaxis with Palivizumab
boolean
C0680251 (UMLS CUI [1,1])
C0021270 (UMLS CUI [1,2])
C1548635 (UMLS CUI [1,3])
C0035235 (UMLS CUI [1,4])
C0199176 (UMLS CUI [1,5])
Elig.phs001201.v2.p1.7
Item
Presence of underlying neuromuscular disorder (i.e., Down's syndrome, cerebral palsy)
boolean
C0009488 (UMLS CUI [1,1])
C0027868 (UMLS CUI [1,2])
Elig.phs001201.v2.p1.8
Item
Immunosuppressive condition (i.e., HIV infection in mother) or use of immunosuppressive medications prior to RSV infection
boolean
C4048329 (UMLS CUI [1,1])
C0021081 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0035235 (UMLS CUI [1,4])
Elig.phs001201.v2.p1.9
Item
Presence of malignancy (i.e., Wilms tumor)
boolean
C0006826 (UMLS CUI [1,1])
C3854307 (UMLS CUI [1,2])
Elig.phs001201.v2.p1.10
Item
Inability to contact for the duration of the study
boolean
C1299582 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
Elig.phs001201.v2.p1.11
Item
Any other condition deemed to place infant at higher risk for severe RSV infection (i.e., NICU transfer at birth, recurrent aspiration)
boolean
C0205394 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
C0035235 (UMLS CUI [1,5])
Elig.phs001201.v2.p1.12
Item
Infants hospitalized for apnea only (hospital cohort only)
boolean
C0019993 (UMLS CUI [1,1])
C0003578 (UMLS CUI [1,2])
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