The Impact of the Use of Recombinant Human Growth Hormone on Attention Hyperactivity Deficit Characteristics in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- ADHD criteria
研究概览
简要总结
Analysis of the short-and long-term impact of recombinant growth hormone on attention deficit and hyperactivity charachteristics in children and adolescents. This will be examined in children prior to GH therapy and 3, 6 and 12 months during treatment, by filling validated questionnaires (Vanderbilt rating scales) evaluating ADHD.
Data will be compared to healthy control group.
详细描述
Background The main objective of this study is to analyze the short-and long-term influence of recombinant growth hormone on clinical and questionnaires based criteria of attention deficit/hyperactivity disorder in children and adolescents. This will be examined in children prior to GH therapy and 3, 6 and 12 months during treatment, by filling validated questionnaires (Vanderbilt rating scales) evaluating ADHD. All participants will be treated by rhGH doses acceptable by the FDA recommendations.
Trial Goal The main goal of this trial is to assess if there is any association between treatment with rhGH during a short period of 3 months, or a long period of 3-12 months and the development of characteristics of ADHD (measurable parameters )
Hypothesis Our research hypothesis, is that although parents fear of hyperreactive symptoms after rGH administration, our study will demonstrate that providing regular management of recombinant human growth hormone therapy over time, will not be associated with significant change in attention deficit/hyperactive characteristics compared to matched age and sex controls who did not receive GH treatment. This prospective case control study format study has been chosen in order to observe and document any behavioural influence with the recommended and standard treatment with GH treatment given according to current guidelines.
Study population and size were decided according to a statistician calculation of 80% power and 5% significance and with a consiideration of 15% drop-out
Trial design An open prospective observational case control study that will recruit children and adolescents prior to initiation of GH treatment. This is a single-site study, however patients who comply with inclusion and exclusion criteria, may be recruited by the media, by representatives of pharmaceutical companies, medical associations and the Children's Endocrinology Association. Every eligible participant, wherever treated for his condition may take part in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children over the age of 6 years, and less than 16 years
- •Children eligible for rhGH treatment according to the following Food and Drug Administration approved indications; Small for gesational age, Idioapathic short stature, GH deficiency and chronic renal failure.
- •Consent of parents / guardian to participate in research
排除标准
- •- Under the age of 6 years and above 16 years
- •Previously diagnosed with neurocognitive disease
- •Previously diagnosed with specific syndromes: Prader-willi syndrome, Turner
- •Previously diagnosed with Attention Deficit/Hyperactivity disorder
结局指标
主要结局
ADHD criteria
时间窗: 12 months
questionnaires analysis will give a definite number. Criteria will be compared between groups
次要结局
未报告次要终点