The Impact of the Use of Recombinant Human Growth Hormone on ADHD Characteristics in Children and Adolescents
The Impact of the Use of Recombinant Human Growth Hormone on ADHD Characteristics in Children and Adolescents
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.
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.

 The study design is to compare, in a controlled case-control manner, prospectively. The
 development of ADHD characteristics in a group of patients from initiation to 12 months of
 treatment with rhGH compared to a similar gender and age controlled group, not treated by
 rhGH.

 Statistical Analysis All data will be presented in mean ,min and max. The data will be
 divided according to age and results.

 Statistical analysis will be performed by ANOVA with repeated measures, which will examine
 the difference between the trial and control group, at the 4 different time points, as well
 as the difference in each patient for itself, the influence of time and the interaction
 between these measures.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  - 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