EUCTR2006-004304-39-DE进行中（未招募）不适用
EUROMUSCULAR CHANGES IN SMALL FOR GESTATIONAL AGE (SGA-) CHILDREN DURING SOMATROPIN THERAPY -A PROSPECTIVE, RANDOMIZED, CONTROLLED, OPEN-LABEL, MULTICENTER TRIAL (SGA-POWER STUDY) - SGA-Power study
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
- 88
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. Pre-pubertal boys between 6 and 10 years of age or girls between 6 and 9 years of age
- •2. Birth length- and/or birth weight-SDS adjusted to gestational age < -2.0 (Voigt et al. 2002, Voigt et al. 2006 or Lawrence et al. 1989)
- •3. Current height-SDS < -2.5 (Brandt/Reinken 1992) and parental adjusted height-SDS < -1 (Hermanussen and Cole 2003)
- •4. Growth velocity SDS < 0 during the last year before inclusion (Brandt/Reinken 1988)
- •5. Girls: Tanner stage 1 breast development (Tanner 1962)
- •6. Boys: Testis volume = 3 ml (Prader 1966)
- •7. Tanner stage 1 pubic hair development (to exclude confounding effect of adrenarche on growth velocity, insulin sensitivity and body composition)
- •8. Evidence of a personally signed and dated informed consent document indicating that both parents of the subject (both legally acceptable representatives) has been informed of all pertinent aspects of the study and oral/written consent of subject due to age specific information has been obtained
- •9. Subject (and a legally acceptable representative) is willing to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •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. Severe SGA (birth weight or length < -4 SD) and clinically relevant dysmorphic features
- •2. Severe pre-maturity (GA < 32 weeks of gestation)
- •3. Severe perinatal complications like asphyxia, sepsis, necrotizing enterocolitis (NEC), respiratory distress syndrome, if associated with long-term sequelae (like short bowel syndrome, bronchopulmonary dysplasia (BPD), cerebral palsy etc)
- •4. Inability to perform one- or two leg jumps from a standing position
- •5. Prior GH treatment
- •6. Other endocrine diseases except for well substituted hypothyroidism (stable replacement therapy for at least 3 months prior to randomization)
- •7. Any severe acute or chronic diseases (neurological, respiratory, gastrointestinal etc) or medication that might influence linear growth, cognitive performance or insulin sensitivity (e.g. prednisolone for more than 7 days in doses above 10 mg per day or other per oral glucocorticosteroids in equivalent doses are not permitted throughout the trial. Treatment with topical or inhaled steroids is permitted). Individuals should not be under treatment of musculoskeletal diseases. Moreover, the administration of neuropharmacological and psychopharmacological drugs is not allowed (including methylphenidate, atomoxetin)
- •8. Known diabetes mellitus
- •9. Active malignancy/tumor or history of malignancy/tumor disease
- •10. Turner syndrome in girls
- •11. Other defined chromosomal aberrations or syndromes (e.g. fetal alcohol syndrome, osteochondrodysplasia), except Silver-Russell syndrome
- •12. Suspected non-compliance or impossibility to follow the treatment schedule, respectively (e.g. social implications)
- •13. Defined neurological defects, e.g. paresis, severe microcephaly
- •14. Severe non-corrected impaired vision
- •15. Ongoing psychotherapy
- •16. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
- •17. Participation in any other study during active treatment phase
- •18. Any other contraindications and warnings referring to the SGA indication and referenced in the actual local SmPC version of Genotropin®
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