A Two Year Multicentre, Randomized Two Arm Study Of Genotropin Treatment In Very Young Children Born Small For Gestational Age: Early Growth And Neurodevelopment(Egn)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 43
- 试验地点
- 17
- 主要终点
- Change From Baseline in Height Standard Deviation Score (SDS) at Month 24.
研究概览
简要总结
To demonstrate the effect on height and psychomotor development of Growth Hormone treatment in very young children starting at an age of 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Months 至 29 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caucasian male or female subjects aged between 19-29 months at Screening Visit
- •Born SGA (birth length and/or weight <-2 SD for gestational age, using country-specific standards).
- •Height below -2.5 SD at screening (19-29 months of age). At least one measurement of length between 12 and 18 months of age. Normal karyotype in girls to exclude Turners syndrome.
排除标准
- •Severe Intra-Uterine Growth Retardation (IUGR) (birth length below - 4 SD for gestational age), if associated with dysmorphic features.
- •Severe prematurity (Gestational Age (GA) <32 weeks of gestation). Ongoing catch-up growth (defined as growth velocity SDS at inclusion >0) based on at least 4 months measurement interval).
- •Severe familial short stature defined as: Father's height below 155 cm or mother's height below 145 cm.
- •Defined neurological defects and/or severe neurodevelopmental delay.
研究组 & 干预措施
Active
The active treatment arm
干预措施: Genotropin (PN-180,307) Somatropin (Drug)
Control
Control
干预措施: Control-no treatment (Drug)
结局指标
主要结局
Change From Baseline in Height Standard Deviation Score (SDS) at Month 24.
时间窗: Baseline and Month 24
Height SDS was calculated at the relevant visit by means of the following formula: Height SDS = (participant height) - (normal height)/normal height standard deviation. Where participant height refers to the participant's height at the relevant visit, and normal height and the normal height standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for height SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
次要结局
- Change From Baseline in Mental Development Using the Mental Development Index (MDI) of Bayley Scale at Month 12.(Baseline and Month 12)
- Change From Baseline in Growth Velocity SDS at Month 24.(Baseline and Month 24)
- Change From Baseline in Height SDS at Month 12.(Baseline and Month 12)
- Change From Baseline in Growth Velocity SDS at Month 12.(Baseline and Month 12)
- Change From Baseline in Psychomotor Development Using the Psychomotor Development Index (PDI) of Bayley Scale at Month 12.(Baseline and Month 12)
- Head Circumference SDS at Months 3, 6, 12, 18 and 24.(Months 3, 6, 12, 18 and 24)
- Change From Baseline in Head Circumference SDS at Months 3, 6, 12, 18 and 24.(Baseline, Months 3, 6, 12, 18 and 24.)
- Change From Baseline in Body Weight at Months 3, 6, 12, 18, and 24.(Baseline, Months 3, 6, 12, 18, and 24)
- Change From Baseline in Body Mass Index (BMI) at Months 3, 6, 12, 18, and 24.(Baseline, Months 3, 6, 12, 18, and 24)