Early hGH Treatment of Symmetrically Born Small for Gestational Age Infants to Prevent Irreversible Neurologic and Psychological Damage and Sequelae
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 主要终点
- Changes in Cognitive assessments (using the Bayley Scales of Infant Development (BSID-III)
研究概览
简要总结
SGA Infants who do not show a developmental catch-up growth within the first 6 months of life fall in the category of SGA children shown to have defects in the GH/IGF-I axis, resulting in partial hGH/IGF-I deficiency.
Up to 1/4 of children born SGA have neurodevelopmental deficits. The partial hGH/IGF-I deficiency in SGA children can be the major or contributory cause of to their neurodevelopmental deficits
To assess the effect of early growth hormone treatment given to symmetrical small for gestational age (SGA) infants not demonstrating catch-up growth on neurodevelopment and growth between birth and 6-12 months.
The study is an innovative research not previously performed for improving neurodevelopmental outcome of SGA infants. As this is the first study of its kind, the safety of use of GH has not been reported, however based on multiple studies assessing use of GH in infants and young children, it is reasonable to similarly expect no short and long-term adverse effects.
The study will take place at the Tel Aviv Medical Center only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symmetrical small for gestational age at birth: weight + length+ head circumference below -2 SD for gestational age.
- •Birth weight of 1200-2200 gr
- •Follow-up of growth until age of 6-12 months
- •Growth parameters below -2 SD at age of 6-12 months and absence of sufficient catch-up.
- •Low growth hormone levels.
排除标准
- •Chromosomal aberration
- •Any congenital syndrome and any syndrome that shows a tendency to uncontrolled cell growth and to develop tumors
- •Major congenital malformation (affecting growth or development)
- •Congenital infection
- •Exposure to teratogenic drugs or drugs affecting development during pregnancy
- •Maternal drug or alcohol abuse.
- •Maternal cancer as well as cancer in 1st degree relatives.
研究组 & 干预措施
hGH, ZOMACTON® (somatropin)
For infants in the treatment group receiving ZOMACTON® (somatropin) growth hormone by injection
干预措施: Human growth hormone,ZOMACTON® (somatropin) (Drug)
结局指标
主要结局
Changes in Cognitive assessments (using the Bayley Scales of Infant Development (BSID-III)
时间窗: Before treatment and 1 year later
using the Bayley Scales of Infant Development (BSID-III)
Changes in Neurological status (formal neurological examination)
时间窗: Before treatment and 1 year later
using formal neurological examination
次要结局
- Changes in X-ray of the hand and wrist(Before treatment and 1 year later)
- Achenbach Child Behavior Checklist (CBCL)(at the end of study after 1 year of treatment)
- Pediatric Quality of life Inventory: the PedsQL measure(after 1 year of treatment)