ISRCTN36828561已完成不适用
A randomized, multicentre, multinational trial to evaluate the safety and efficacy of Growth Hormone treatment at varying doses in short children, born small for gestational age (SGA)
Rigshospitalet (Denmark)0 个研究点目标入组 34 人开始时间: 2010年4月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
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. Small for gestational age (body weight [BW] less than -2 SD according to country specific references)
- •2. Gestational age at birth more than 28 weeks
- •3. Short at 4 years of age (Height SDS less than -2.5 according to country specific references)
- •4. Short for parental height (HSDS greater than 1 SD below parental adjusted HSDS (mid parental height SDS)
- •5. Age 4 - 8.99 years (girls) and 4 - 9.99 years (boys)
- •6. Prepubertal at start of treatment (largest testis volume less than 4 ml, breast stage 1)
- •7. Height records must be available for 6 months prior to inclusion into the study
- •8. Height velocity SDS less than 0 during last 6 months (according to country specific references)
- •9. Subjects must be naïve to growth hormone therapy
排除标准
- •1. Known or suspected allergy to growth hormone
- •2. Previous participation in growth hormone trial
- •3. Severe mental retardation as judged by the investigator
- •4. Previous or active malignancy
- •5. Benign intracranial hypertension (present or past)
- •6. Diabetes
- •7. Growth retardation due to chronic diseases, syndromes (like FAS) and chromosomal anomalies (except for Silver Russell syndrome)
- •8. Psychological problems likely to lead to significant non-compliance
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