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
- 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
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