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临床试验/ISRCTN57824306
ISRCTN57824306已完成未知

Trial to Reduce Insulin dependent diabetes mellitus in the Genetically at Risk: a randomised controlled trial

John P. Robarts Research Institute (Canada)0 个研究点目标入组 2,730 人开始时间: 2005年9月26日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
2,730

研究概览

简要总结

  1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17550422 2. 2013 recruitment and retention strategies in: http://www.ncbi.nlm.nih.gov/pubmed/24216218 3. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29297078 (added 12/04/2019)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. The biological parents and/or full (not half) sibling of the newborn infant has type 1 diabetes as defined by the World Health Organization
  • 2. The infant?s parents or legal guardians give signed consent to participate

排除标准

  • 1. An older sibling of the newborn infant has been included in the TRIGR intervention
  • 2. Multiple gestation
  • 3. The parents are unwilling or unable to feed the infant cow?s milk based products for any reason (e.g. religious, cultural)
  • 4. The newborn infant has a recognisable severe illness such as those due to chromosomal abnormality, congenital malformation, respiratory failure needing assisted ventilation, enzyme deficiencies etc.
  • 5. The gestational age of the newborn infant is less than 35 weeks
  • 6. The infant is older than 7 days at randomisation
  • 7. Inability of the family to take part in the study (e.g. the family has no access to any of the Study Centres, the family has no telephone)
  • 8. The infant has received any infant formula other than Nutramigen prior to randomisation
  • 9. No HLA sample drawn before the age of 8 days

研究者

发起方
John P. Robarts Research Institute (Canada)

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