EUCTR2004-004781-33-DE进行中（未招募）不适用
Somatropin Therapy for Short Children Born of Premature Gestation: A Controlled, Prospective Randomized, Multicenter Study with an Untreated Control Group - N/A
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Prepubertal caucasian boys between 4 and 10 years of age and girls between 4 and 9 years of age.
- •Girls: Tanner stage 1 breast development
- •Boys: Testis volume = 3 ml
- •Tanner stage 1 pubic hair development (to exclude confounding effect of adrenarche on growth velocity, insulin sensitivity and body composition).
- •(In case of any signs or symptoms of gonadal puberty a GnRH-test must decide if the subject is still prepubertal)
- •2) Height = -2 SD for chronological age (Brandt/Reinken).
- •3) Growth velocity SDS below 0 SD for chronological age (Brandt/Reinken based on 12 ± 3 months observation period before screening).
- •4) Premature born defined as = 1500 g birth weight.
- •5) GH sufficiency (GH level >7 µg/l following any routine GH stimulation test).
- •6) Written informed consent of both parents (legal guardians) and oral/written consent of patient due to age specific information.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Other endocrine diseases except for well substituted hypothyroidism.
- •2) Severe chronic diseases or medication that might influence linear growth or insulin sensitivity (e.g. Glucocorticoids).
- •3) Positive GAD (Glutamatdecarboxylase, GAD65) and IA-2 (Tyrosinphosphatase) antibodies (for type 1 diabetes).
- •(Note: A positive result of antibody determinations confirms type 1 diabetes but a negative result of GAD antibodies does not exclude type 1 diabetes).
- •4) History of malignancy.
- •5) Children who meet all of the following criteria:
- •· actual body height <-2,5 SDS (Brandt/Reinken) and parent adjusted target height < -1 SDS (Hermanussen + Cole)
- •· length and/or body weight retardations adjusted to gestational age at birth <-2,0 SDS (Lawrence et al., 1989, Voigt et al., 1996)
- •· children with chronological age =4 years and
- •· growth velocity < 0 SDS during the last year before inclusion.
- •6) Chromosomal aberrations or syndromes.
- •7) Suspected non-compliance or impossibility to follow the two or three year treatment schedule, respectively (e.g. social implications).
- •8) Severe hemiparesis and severe CNS defects.
- •9) Retinopathia = third degree or coagulation treatment.
- •10) Participation in any other clinical trial during active treatment phase.
- •11) Other severe acute or chronic medical or psychiatric condition or clinically relevant laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
研究者
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