ID

15730

Description

TRIGR - Primary Prevention Study for Type 1 Diabetes in Children at Risk; ODM derived from: https://clinicaltrials.gov/show/NCT00179777

Link

https://clinicaltrials.gov/show/NCT00179777

Keywords

Versions (2)
  1. 6/5/16 6/5/16 -
  2. 6/10/16 6/10/16 - Julian Varghese
Uploaded on

June 10, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT00179777

English

Eligibility Diabetes Mellitus, Type 1 NCT00179777

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
biological parent and/or full (not half) sibling of the newborn infant has type 1 diabetes as defined by the world health organization
Description

type 1 diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011854
the infant's parent or legal guardians give signed consent to participate
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
an older sibling of the newborn infant has been included in the trigr intervention
Description

trigr intervention

Data type

boolean

Alias
UMLS CUI [1,1]
C0337511
UMLS CUI [1,2]
C2348568
multiple gestation
Description

multiple gestation

Data type

boolean

Alias
UMLS CUI [1]
C1403697
the parents are unwilling or unable to feed the infant cow's milk based products for any reason (e.g., religious, cultural).
Description

unable to feed the infant cows milk

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0349374
the newborn infant has a recognizable severe illness such as those due to chromosomal abnormality, congenital malformation, respiratory failure needing assisted ventilation, enzyme deficiencies, etc.
Description

severe illness

Data type

boolean

Alias
UMLS CUI [1]
C0008625
UMLS CUI [2]
C0000768
UMLS CUI [3]
C1145670
UMLS CUI [4]
C0149676
the gestational age of the newborn infant is less than 35 weeks.
Description

gestational age

Data type

boolean

Alias
UMLS CUI [1]
C0017504
the infant is older than 7 days at randomization.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
inability of the family to take part in the study (e.g. the family has no access to any of the study centers, the family has no telephone).
Description

inability of the family to take part in the study

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0439801
the infant has received any infant formula other than nutramigen prior to randomization.
Description

any infant formula

Data type

boolean

Alias
UMLS CUI [1]
C0150589
no hla sample drawn before the age of 8 days.
Description

hla sample drawn

Data type

boolean

Alias
UMLS CUI [1]
C0019633
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Similar models

Eligibility Diabetes Mellitus, Type 1 NCT00179777

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
type 1 diabetes
Item
biological parent and/or full (not half) sibling of the newborn infant has type 1 diabetes as defined by the world health organization
boolean
C0011854 (UMLS CUI [1])
informed consent
Item
the infant's parent or legal guardians give signed consent to participate
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
trigr intervention
Item
an older sibling of the newborn infant has been included in the trigr intervention
boolean
C0337511 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
multiple gestation
Item
multiple gestation
boolean
C1403697 (UMLS CUI [1])
unable to feed the infant cows milk
Item
the parents are unwilling or unable to feed the infant cow's milk based products for any reason (e.g., religious, cultural).
boolean
C1321605 (UMLS CUI [1,1])
C0349374 (UMLS CUI [1,2])
severe illness
Item
the newborn infant has a recognizable severe illness such as those due to chromosomal abnormality, congenital malformation, respiratory failure needing assisted ventilation, enzyme deficiencies, etc.
boolean
C0008625 (UMLS CUI [1])
C0000768 (UMLS CUI [2])
C1145670 (UMLS CUI [3])
C0149676 (UMLS CUI [4])
gestational age
Item
the gestational age of the newborn infant is less than 35 weeks.
boolean
C0017504 (UMLS CUI [1])
age
Item
the infant is older than 7 days at randomization.
boolean
C0001779 (UMLS CUI [1])
inability of the family to take part in the study
Item
inability of the family to take part in the study (e.g. the family has no access to any of the study centers, the family has no telephone).
boolean
C2348568 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
any infant formula
Item
the infant has received any infant formula other than nutramigen prior to randomization.
boolean
C0150589 (UMLS CUI [1])
hla sample drawn
Item
no hla sample drawn before the age of 8 days.
boolean
C0019633 (UMLS CUI [1])
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