ISRCTN96883876已完成未知
Growth hormone treatment of children after IntraUterine Growth Retardation: IUGR-2 study
Erasmus Medical Centre (The Netherlands)0 个研究点目标入组 170 人开始时间: 2006年1月27日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 170
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Birth weight less than P3 for gestational age (according to Usher and McLean)
- •2. Neonatal period without signs of severe asphyxia (defined by Apgar score less than 3 after 5 minutes), without signs of chronic lung disease (such as bronchopulmonary dysplasia)
- •3. No catch-up growth defined as obtaining a height of P3 within the first 2 years of life or at a later stage
- •4. Height velocity (cm/year) for chronological age P50
- •5. Chronological age at the start of treatment: 3.0 - 7.99 years (boys and girls)
- •6. Prepubertal signs defined as Tanner stage 1 or testicular volume less than 4 ml
- •7. Well documented growth data from birth up to 2 years and at least 1 year before the start of the study
排除标准
- •1. Any endocrine or metabolic disorder such as diabetes mellitus, diabetes insipidus, hypothyroidism or inborn errors of metabolism, except of GHD
- •2. Disorders of genito-urinary tract, cardiopulmonary or gastrointestinal tract, or nervous systems, nutritional and/or vitamin deficiencies
- •3. Chromosomal abnormalities or signs of a syndrome, except of Silver-Russell Syndrome (SRS)
- •4. Chondrodysplasia
- •5. Hydrocephalus
- •6. Active malignancy or increased risk of leukaemia
- •7. Serious suspicion of psychosocial dwarfism (emotional deprivation)
- •8. Previous anabolic sex steroid or GH therapy
研究者
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