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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02929953
Date of registration: 08/10/2016
Prospective Registration: No
Primary sponsor: Assaf Harofeh MC
Public title: Prematurity Prevalence Among T1D Patients and Its Characteristics Compared With Premature-born Non-diabetic Patients T1Dpremies
Scientific title: Prevalence of Premature Birth History Among Type 1 Diabetes Mellitus (T1D) Patients and Characteristics of Premature Born Children Who Develop T1D Compared With Those Who do Not
Date of first enrolment: January 2014
Target sample size: 3600
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02929953
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Israel
Contacts
Name:     marianna Rachmiel, md
Address: 
Telephone:
Email:
Affiliation:  Assaf Haroffeh Medical Center
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients diagnosed with T1D

2. Patients treated in one of the 13 participating centers

3. For the case-control portion of the study, all children born between
1.1.1990-31.12.2013 and admitted to NICU medical centers that have been included in
the original cohort portion

4. Patients for whom a complete medical record is available

Exclusion Criteria:

1. Lack of birth data

2. Unknown type of diabetes

3. For case control portion, an incomplete medical record/inadequate documentation



Age minimum: 1 Year
Age maximum: 25 Years
Gender: All
Health Condition(s) or Problem(s) studied
Type 1 Diabetes Mellitus
Intervention(s)
Other: chart review
Primary Outcome(s)
prematurity prevalence among T1D patients [Time Frame: 1 years]
Secondary Outcome(s)
food exposure of premature who developed T1DM compared with prematures who did not develop diabetes [Time Frame: 1 years]
Medications exposure in premature who developed T1DM compared with prematures who did not develop diabetes [Time Frame: 1 years]
Secondary ID(s)
183/13
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Shaare Zedek Medical Center
HaEmek Medical Center, Israel
Tel-Aviv Sourasky Medical Center
Schneider Children's Medical Center, Israel
Soroka University Medical Center
Rambam Health Care Campus
Wolfson Medical Center
Hadassah Medical Organization
Kaplan Medical Center
Maccabi Healthcare Services, Israel
Ziv Medical Center
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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