Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02973061 |
| Other study ID # |
240/14 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2015 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
August 2022 |
| Source |
Assaf-Harofeh Medical Center |
| Contact |
Marianna Rachmiel, md |
| Phone |
97289542007 |
| Email |
mariannar[@]asaf.health.gov.il |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
