Engelsk

Eligibility Criteria

5 Formulär  
  1. StudyEvent: Prematurity Respiratory Outcomes Immune System and Microbiome Study
    1. Eligibility Criteria
    2. The subject consent file includes subject IDs, consent information, subject aliases, and study ID.
    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 IDs, cohort, sex, ethnic, race, gestational ages at birth and discharge, birth mode, bronchopulmonary dysplasia status, persistent repiratory disease after one year, oxygen AUC (Area Under the ROC curve) at 7 and 14 days, days on 7 variables (oxygen, mechanical ventilation, high frequency ventilation, cpap, nasal cannula gt 1 lmp, any respiratory support, and nasal cannula), maximum mean airway pressure, last PMA and DOL on ETT for GT 2 days in a row, exposure to furry animals in the home, asthma, allergies and eczema within siblings, BMI of the mother at the time of delivery, chlorioamnionitis, season of birth, derived respiratory severity score, oxygen AUC for first 14 days of life, and difference between FIO2 weeks 1 and 2.
    5. This sample attributes table contains sample IDs, visit, postmenstrual ages at time of nsasal or rectal swab sampling, day of life of the nasal or rectal tests, body site, read counts, analyte type, tumor status, histological type, region of bacteria being sequenced, presence of bacteria or virus (Adenovirus, Bocavirus, Bordetella pertussis, Coronavirus 1-4, Chlamydophila pneumoniae, Enterobacteriaceae, Flu A, Flu B, Haemophilus influenzae, Human metapneumovirus, Moraxella, Mycoplasma hominis, Mycoplasma pneumoniae, parechovirus, PIV 1-3, Rhinovirus, RSV, Streptococcus pneumoniae, and Ureaplasma) within the sample, corresponding bacteria or virus classification, hospital admissions, due to wheezing or breathing problems, admitted to intensive care, admissions due to RSV, sick visits, sick visits due to wheezing or breathing problems or wheezing unknown, has baby chest sounded wheezy or whistling, occurred with or without colds, chest wheezy during daytime or nighttime, diagnosed with wheezing by doctor, cough without cold, coughing during daytime or nighttime, number of colds, breathing and heart rate monitor, oxygen therapy, CPAP or BIPAP, ventilator, trach or breathing tube, feeding tube in nose or stomach, other equipment used, is baby receiving breast milk, is baby receiving breast milk exclusively, did baby receive breast milk since last visit, for how many months did baby receive breast milk for more than half of feedings, does baby eat any non-milk foods, and what non-milk foods does baby eat.
Inclusion criteria
Beskrivning

Inclusion criteria

Alias
UMLS CUI [1,1]
C1512693
Signed Informed Consent from parent(s) or legal guardian(s)
Beskrivning

Elig.phs001347.v3.p2.2

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [1,3]
C1274041
Preterm infants born at gestational age 23 0/7 to 35 6/7 weeks
Beskrivning

Elig.phs001347.v3.p2.3

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4048294
UMLS CUI [1,2]
C0017504
Preterm infants admitted to the URMC NICU or Normal Newborn Nursery
Beskrivning

Elig.phs001347.v3.p2.4

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4048294
UMLS CUI [1,2]
C0000872
UMLS CUI [1,3]
C0809949
UMLS CUI [1,4]
C0021709
UMLS CUI [2,1]
C4048294
UMLS CUI [2,2]
C0000872
UMLS CUI [2,3]
C0809949
UMLS CUI [2,4]
C1960106
Infants less than or equal to 7 days old
Beskrivning

Elig.phs001347.v3.p2.5

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0021270
UMLS CUI [1,3]
C0439090
Attending physician agreement
Beskrivning

Elig.phs001347.v3.p2.6

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1320929
UMLS CUI [1,2]
C0680240
Healthy term infants 37 0/7 to 41 6/7 weeks gestation
Beskrivning

Elig.phs001347.v3.p2.7

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3898900
UMLS CUI [1,2]
C0021270
UMLS CUI [1,3]
C0017504
Recruited prior to delivery, or from the birthing centers and labor and delivery floor
Beskrivning

Elig.phs001347.v3.p2.8

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242800
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C2053594
UMLS CUI [2,1]
C0242800
UMLS CUI [2,2]
C3887776
UMLS CUI [3,1]
C0242800
UMLS CUI [3,2]
C0085142
Infants less than or equal to 7 days old
Beskrivning

Elig.phs001347.v3.p2.9

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0021270
UMLS CUI [1,3]
C0439090
Signed Informed Consent from parent(s) or legal guardian(s)
Beskrivning

Elig.phs001347.v3.p2.10

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [1,3]
C1274041
Exclusion criteria
Beskrivning

Exclusion criteria

Alias
UMLS CUI [1,1]
C0680251
Considered to be non-viable (decision by clinical care team to limit life-saving therapies)
Beskrivning

Elig.phs001347.v3.p2.11

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C0086390
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C0199171
UMLS CUI [2,1]
C5556942
Known congenital heart disease, not including patent ductus arteriosus (PDA), hemodynamically insignificant ventricular septal defect (VSD) or atrial septal defect (ASD)
Beskrivning

Elig.phs001347.v3.p2.12

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018798
UMLS CUI [1,2]
C1705847
UMLS CUI [1,3]
C0013274
UMLS CUI [1,4]
C0578150
UMLS CUI [1,5]
C0018818
UMLS CUI [1,6]
C0018817
Known structural abnormalities of the upper airway, lungs, or chest wall
Beskrivning

Elig.phs001347.v3.p2.13

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678594
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0458578
UMLS CUI [1,4]
C0024109
UMLS CUI [1,5]
C0205076
Known other congenital malformations or syndromes that adversely affect life expectancy or cardiopulmonary development (i.e., neuromuscular disease, trisomy 21).
Beskrivning

Elig.phs001347.v3.p2.14

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0023671
UMLS CUI [2,1]
C0000768
UMLS CUI [2,2]
C0553534
UMLS CUI [2,3]
C0424605
Known to be born to women who are human immunodeficiency virus (HIV) positive (HIV testing is not required prior to study entry but is available for most mothers-to-be and is performed on all newborns in NY state).
Beskrivning

Elig.phs001347.v3.p2.15

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026591
UMLS CUI [1,2]
C0019699
Known congenital or acquired immune deficiency
Beskrivning

Elig.phs001347.v3.p2.16

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1855771
UMLS CUI [1,2]
C1744681
UMLS CUI [2,1]
C1855771
UMLS CUI [2,2]
C0439661
Family is unlikely to be available for long-term follow-up.
Beskrivning

Elig.phs001347.v3.p2.17

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015576
UMLS CUI [1,2]
C0750558
UMLS CUI [1,3]
C1517942
No legal guardian who speaks and reads English.
Beskrivning

Elig.phs001347.v3.p2.18

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0023226
UMLS CUI [1,3]
C0564215
UMLS CUI [1,4]
C0586740
UMLS CUI [1,5]
C0376245
Specifically for the term Infants, as healthy infants, no *NICU* admission prior to consent.
Beskrivning

Elig.phs001347.v3.p2.19

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C3898900
UMLS CUI [1,3]
C0021270
UMLS CUI [1,4]
C1298908
UMLS CUI [1,5]
C0021709
UMLS CUI [1,6]
C0332152
UMLS CUI [1,7]
C1511481
Any infant with a diagnosis of hypertension, hyperthyroidism, seizures, arrhythmias, or sensitivity to sympathomimetic amines will be excluded from the BDR assessment.
Beskrivning

Elig.phs001347.v3.p2.20

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3166112
UMLS CUI [1,2]
C2828389
UMLS CUI [1,3]
C0020538
UMLS CUI [1,4]
C0020550
UMLS CUI [1,5]
C0036572
UMLS CUI [1,6]
C0003811
UMLS CUI [1,7]
C0020517
UMLS CUI [1,8]
C0002509
Any infant with hypersensitivity to any of components of albuterol sulfate will be excluded from the BDR assessment. An infant or child with such history may remain eligible for the remainder of the study if they qualify by other inclusion and exclusion criteria.
Beskrivning

Elig.phs001347.v3.p2.21

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0543495
UMLS CUI [1,3]
C2828389
UMLS CUI [1,4]
C3166112
UMLS CUI [2,1]
C1302261
UMLS CUI [2,2]
C0020517
UMLS CUI [2,3]
C0262926
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Similar models

Eligibility Criteria

5 Formulär
  1. StudyEvent: Prematurity Respiratory Outcomes Immune System and Microbiome Study
    1. Eligibility Criteria
    2. The subject consent file includes subject IDs, consent information, subject aliases, and study ID.
    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 IDs, cohort, sex, ethnic, race, gestational ages at birth and discharge, birth mode, bronchopulmonary dysplasia status, persistent repiratory disease after one year, oxygen AUC (Area Under the ROC curve) at 7 and 14 days, days on 7 variables (oxygen, mechanical ventilation, high frequency ventilation, cpap, nasal cannula gt 1 lmp, any respiratory support, and nasal cannula), maximum mean airway pressure, last PMA and DOL on ETT for GT 2 days in a row, exposure to furry animals in the home, asthma, allergies and eczema within siblings, BMI of the mother at the time of delivery, chlorioamnionitis, season of birth, derived respiratory severity score, oxygen AUC for first 14 days of life, and difference between FIO2 weeks 1 and 2.
    5. This sample attributes table contains sample IDs, visit, postmenstrual ages at time of nsasal or rectal swab sampling, day of life of the nasal or rectal tests, body site, read counts, analyte type, tumor status, histological type, region of bacteria being sequenced, presence of bacteria or virus (Adenovirus, Bocavirus, Bordetella pertussis, Coronavirus 1-4, Chlamydophila pneumoniae, Enterobacteriaceae, Flu A, Flu B, Haemophilus influenzae, Human metapneumovirus, Moraxella, Mycoplasma hominis, Mycoplasma pneumoniae, parechovirus, PIV 1-3, Rhinovirus, RSV, Streptococcus pneumoniae, and Ureaplasma) within the sample, corresponding bacteria or virus classification, hospital admissions, due to wheezing or breathing problems, admitted to intensive care, admissions due to RSV, sick visits, sick visits due to wheezing or breathing problems or wheezing unknown, has baby chest sounded wheezy or whistling, occurred with or without colds, chest wheezy during daytime or nighttime, diagnosed with wheezing by doctor, cough without cold, coughing during daytime or nighttime, number of colds, breathing and heart rate monitor, oxygen therapy, CPAP or BIPAP, ventilator, trach or breathing tube, feeding tube in nose or stomach, other equipment used, is baby receiving breast milk, is baby receiving breast milk exclusively, did baby receive breast milk since last visit, for how many months did baby receive breast milk for more than half of feedings, does baby eat any non-milk foods, and what non-milk foods does baby eat.
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion criteria
C1512693 (UMLS CUI [1,1])
Elig.phs001347.v3.p2.2
Item
Signed Informed Consent from parent(s) or legal guardian(s)
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C1274041 (UMLS CUI [1,3])
Elig.phs001347.v3.p2.3
Item
Preterm infants born at gestational age 23 0/7 to 35 6/7 weeks
boolean
C4048294 (UMLS CUI [1,1])
C0017504 (UMLS CUI [1,2])
Elig.phs001347.v3.p2.4
Item
Preterm infants admitted to the URMC NICU or Normal Newborn Nursery
boolean
C4048294 (UMLS CUI [1,1])
C0000872 (UMLS CUI [1,2])
C0809949 (UMLS CUI [1,3])
C0021709 (UMLS CUI [1,4])
C4048294 (UMLS CUI [2,1])
C0000872 (UMLS CUI [2,2])
C0809949 (UMLS CUI [2,3])
C1960106 (UMLS CUI [2,4])
Elig.phs001347.v3.p2.5
Item
Infants less than or equal to 7 days old
boolean
C0001779 (UMLS CUI [1,1])
C0021270 (UMLS CUI [1,2])
C0439090 (UMLS CUI [1,3])
Elig.phs001347.v3.p2.6
Item
Attending physician agreement
boolean
C1320929 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])
Elig.phs001347.v3.p2.7
Item
Healthy term infants 37 0/7 to 41 6/7 weeks gestation
boolean
C3898900 (UMLS CUI [1,1])
C0021270 (UMLS CUI [1,2])
C0017504 (UMLS CUI [1,3])
Elig.phs001347.v3.p2.8
Item
Recruited prior to delivery, or from the birthing centers and labor and delivery floor
boolean
C0242800 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2053594 (UMLS CUI [1,3])
C0242800 (UMLS CUI [2,1])
C3887776 (UMLS CUI [2,2])
C0242800 (UMLS CUI [3,1])
C0085142 (UMLS CUI [3,2])
Elig.phs001347.v3.p2.9
Item
Infants less than or equal to 7 days old
boolean
C0001779 (UMLS CUI [1,1])
C0021270 (UMLS CUI [1,2])
C0439090 (UMLS CUI [1,3])
Elig.phs001347.v3.p2.10
Item
Signed Informed Consent from parent(s) or legal guardian(s)
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C1274041 (UMLS CUI [1,3])
Item Group
Exclusion criteria
C0680251 (UMLS CUI [1,1])
Elig.phs001347.v3.p2.11
Item
Considered to be non-viable (decision by clinical care team to limit life-saving therapies)
boolean
C0679006 (UMLS CUI [1,1])
C0086390 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0199171 (UMLS CUI [1,4])
C5556942 (UMLS CUI [2,1])
Elig.phs001347.v3.p2.12
Item
Known congenital heart disease, not including patent ductus arteriosus (PDA), hemodynamically insignificant ventricular septal defect (VSD) or atrial septal defect (ASD)
boolean
C0018798 (UMLS CUI [1,1])
C1705847 (UMLS CUI [1,2])
C0013274 (UMLS CUI [1,3])
C0578150 (UMLS CUI [1,4])
C0018818 (UMLS CUI [1,5])
C0018817 (UMLS CUI [1,6])
Elig.phs001347.v3.p2.13
Item
Known structural abnormalities of the upper airway, lungs, or chest wall
boolean
C0678594 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0458578 (UMLS CUI [1,3])
C0024109 (UMLS CUI [1,4])
C0205076 (UMLS CUI [1,5])
Elig.phs001347.v3.p2.14
Item
Known other congenital malformations or syndromes that adversely affect life expectancy or cardiopulmonary development (i.e., neuromuscular disease, trisomy 21).
boolean
C0000768 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
C0000768 (UMLS CUI [2,1])
C0553534 (UMLS CUI [2,2])
C0424605 (UMLS CUI [2,3])
Elig.phs001347.v3.p2.15
Item
Known to be born to women who are human immunodeficiency virus (HIV) positive (HIV testing is not required prior to study entry but is available for most mothers-to-be and is performed on all newborns in NY state).
boolean
C0026591 (UMLS CUI [1,1])
C0019699 (UMLS CUI [1,2])
Elig.phs001347.v3.p2.16
Item
Known congenital or acquired immune deficiency
boolean
C1855771 (UMLS CUI [1,1])
C1744681 (UMLS CUI [1,2])
C1855771 (UMLS CUI [2,1])
C0439661 (UMLS CUI [2,2])
Elig.phs001347.v3.p2.17
Item
Family is unlikely to be available for long-term follow-up.
boolean
C0015576 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
C1517942 (UMLS CUI [1,3])
Elig.phs001347.v3.p2.18
Item
No legal guardian who speaks and reads English.
boolean
C1298908 (UMLS CUI [1,1])
C0023226 (UMLS CUI [1,2])
C0564215 (UMLS CUI [1,3])
C0586740 (UMLS CUI [1,4])
C0376245 (UMLS CUI [1,5])
Elig.phs001347.v3.p2.19
Item
Specifically for the term Infants, as healthy infants, no *NICU* admission prior to consent.
boolean
C2348235 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0021270 (UMLS CUI [1,3])
C1298908 (UMLS CUI [1,4])
C0021709 (UMLS CUI [1,5])
C0332152 (UMLS CUI [1,6])
C1511481 (UMLS CUI [1,7])
Elig.phs001347.v3.p2.20
Item
Any infant with a diagnosis of hypertension, hyperthyroidism, seizures, arrhythmias, or sensitivity to sympathomimetic amines will be excluded from the BDR assessment.
boolean
C3166112 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0020538 (UMLS CUI [1,3])
C0020550 (UMLS CUI [1,4])
C0036572 (UMLS CUI [1,5])
C0003811 (UMLS CUI [1,6])
C0020517 (UMLS CUI [1,7])
C0002509 (UMLS CUI [1,8])
Elig.phs001347.v3.p2.21
Item
Any infant with hypersensitivity to any of components of albuterol sulfate will be excluded from the BDR assessment. An infant or child with such history may remain eligible for the remainder of the study if they qualify by other inclusion and exclusion criteria.
boolean
C0020517 (UMLS CUI [1,1])
C0543495 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C3166112 (UMLS CUI [1,4])
C1302261 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2,3])
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