Prematurity Prevalence Among T1D Patients and Its Characteristics Compared With Premature-born Non-diabetic Patients

NCT02929953 | Completed

• 1 other identifier: 183/13
• Study Type: observational
• Target: 3,600
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study are:

1. 1.To assess the prevalence of prematurity, especially early prematurity, among T1D patients, and compare it to the prematurity prevalence among the non-diabetic general population in Israel.
2. 2.To characterize epidemiological and clinical factors that differ between premature-born patients that developed T1D and those that have not, including the nutritional and therapeutic properties in NICU.

Conditions

Type 1 Diabetes Mellitus

Keywords

premature birth; risk factor; type 1 diabetes mellitus; seasonality; prevalence; enteral feeding; immunomodulating medications; early onset

Outcome Measures

Primary Outcomes (1)

• prematurity prevalence among T1D patients

  the number of premature born among those with type 1 diaetes compared to prematurity in health non diabetic population

  1 years

Secondary Outcomes (2)

• food exposure of premature who developed T1DM compared with prematures who did not develop diabetes

  1 years

• Medications exposure in premature who developed T1DM compared with prematures who did not develop diabetes

  1 years

Study Arms (2)

Diabetes mellitus type 1

all T1DM patients in Israel, born during 2000-2013 and diagnosed prior to January 2015. chart review

Other: chart review

Non-diabetic

non-diabetic general population born in Israel during 2000-2013, according to the Israeli Health Ministry's Birth Registry (IHMBR) chart review

Other: chart review

Interventions

chart review OTHER

data from charts and from registries will be compared

Diabetes mellitus type 1; Non-diabetic

Eligibility Criteria

• Age: 1 Year - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All T1D patients in Israel, born during 1990-2013 and diagnosed prior to January 2015, time of data collection. Inclusion criteria included all patients diagnosed as T1D by a pediatric endocrinologist according to the American Diabetes Association criteria, and treated for their T1D with insulin. Patients are identified from registries of the 13 participating centers.

You may qualify if:

• Patients diagnosed with T1D
• Patients treated in one of the 13 participating centers
• 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
• Patients for whom a complete medical record is available

You may not qualify if:

• Lack of birth data
• Unknown type of diabetes
• For case control portion, an incomplete medical record/inadequate documentation

Sponsors & Collaborators

• Assaf Harofeh MC: lead
• Shaare Zedek Medical Center: collaborator
• Wolfson Medical Center: collaborator
• Ziv Medical Center: collaborator
• Schneider Children's Medical Center, Israel: collaborator
• Tel-Aviv Sourasky Medical Center: collaborator
• Maccabi Healthcare Services, Israel: collaborator
• Kaplan Medical Center: collaborator
• HaEmek Medical Center, Israel: collaborator
• Soroka University Medical Center: collaborator
• Rambam Health Care Campus: collaborator
• Hadassah Medical Organization: collaborator

Study Sites (1)

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

Related Publications (22)

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• Working Group Of Pediatrics Chinese Society Of Parenteral And Enteral Nutrition, Working Group Of Neonatology Chinese Society Of Pediatrics, Working Group Of Neonatal Surgery Chinese Society Of Pediatric Surgery. CSPEN guidelines for nutrition support in neonates. Asia Pac J Clin Nutr. 2013;22(4):655-63. doi: 10.6133/apjcn.2013.22.4.21.

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• Zeitlin J, Szamotulska K, Drewniak N, Mohangoo AD, Chalmers J, Sakkeus L, Irgens L, Gatt M, Gissler M, Blondel B; Euro-Peristat Preterm Study Group. Preterm birth time trends in Europe: a study of 19 countries. BJOG. 2013 Oct;120(11):1356-65. doi: 10.1111/1471-0528.12281. Epub 2013 May 24.

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• Cardwell CR, Carson DJ, Patterson CC. Parental age at delivery, birth order, birth weight and gestational age are associated with the risk of childhood Type 1 diabetes: a UK regional retrospective cohort study. Diabet Med. 2005 Feb;22(2):200-6. doi: 10.1111/j.1464-5491.2005.01369.x.

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• Algert CS, McElduff A, Morris JM, Roberts CL. Perinatal risk factors for early onset of Type 1 diabetes in a 2000-2005 birth cohort. Diabet Med. 2009 Dec;26(12):1193-7. doi: 10.1111/j.1464-5491.2009.02878.x.

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  PMID: 26552054 BACKGROUND

• Adar A, Shalitin S, Eyal O, Loewenthal N, Pinhas-Hamiel O, Levy M, Dally-Gottfried O, Landau Z, Zung A, Levy-Khademi F, Zangen D, Tenenbaum-Rakover Y, Rachmiel M. Prevalence of early and late prematurity is similar among pediatric type 1 diabetes patients and the general population. Diabetes Metab Res Rev. 2018 Jul;34(5):e2996. doi: 10.1002/dmrr.2996. Epub 2018 Mar 24.

  PMID: 29471580 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Premature Birth

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• marianna Rachmiel, md

  Assaf Haroffeh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assaf-Harofeh Medical Center

Study Record Dates

• First Submitted: October 8, 2016
• First Posted: October 11, 2016
• Study Start: January 1, 2014
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)