<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02973061</url>
  </required_header>
  <id_info>
    <org_study_id>240/14</org_study_id>
    <nct_id>NCT02973061</nct_id>
  </id_info>
  <brief_title>The Impact of the Use of Recombinant Human Growth Hormone on ADHD Characteristics in Children and Adolescents</brief_title>
  <official_title>The Impact of the Use of Recombinant Human Growth Hormone on Attention Hyperactivity Deficit Characteristics in Children and Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assaf-Harofeh Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assaf-Harofeh Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Analysis of the short-and long-term impact of recombinant growth hormone on attention deficit&#xD;
      and hyperactivity charachteristics in children and adolescents. This will be examined in&#xD;
      children prior to GH therapy and 3, 6 and 12 months during treatment, by filling validated&#xD;
      questionnaires (Vanderbilt rating scales) evaluating ADHD.&#xD;
&#xD;
      Data will be compared to healthy control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background The main objective of this study is to analyze the short-and long-term influence&#xD;
      of recombinant growth hormone on clinical and questionnaires based criteria of attention&#xD;
      deficit/hyperactivity disorder in children and adolescents. This will be examined in children&#xD;
      prior to GH therapy and 3, 6 and 12 months during treatment, by filling validated&#xD;
      questionnaires (Vanderbilt rating scales) evaluating ADHD. All participants will be treated&#xD;
      by rhGH doses acceptable by the FDA recommendations.&#xD;
&#xD;
      Trial Goal The main goal of this trial is to assess if there is any association between&#xD;
      treatment with rhGH during a short period of 3 months, or a long period of 3-12 months and&#xD;
      the development of characteristics of ADHD (measurable parameters )&#xD;
&#xD;
      Hypothesis Our research hypothesis, is that although parents fear of hyperreactive symptoms&#xD;
      after rGH administration, our study will demonstrate that providing regular management of&#xD;
      recombinant human growth hormone therapy over time, will not be associated with significant&#xD;
      change in attention deficit/hyperactive characteristics compared to matched age and sex&#xD;
      controls who did not receive GH treatment. This prospective case control study format study&#xD;
      has been chosen in order to observe and document any behavioural influence with the&#xD;
      recommended and standard treatment with GH treatment given according to current guidelines.&#xD;
&#xD;
      Study population and size were decided according to a statistician calculation of 80% power&#xD;
      and 5% significance and with a consiideration of 15% drop-out&#xD;
&#xD;
      Trial design An open prospective observational case control study that will recruit children&#xD;
      and adolescents prior to initiation of GH treatment. This is a single-site study, however&#xD;
      patients who comply with inclusion and exclusion criteria, may be recruited by the media, by&#xD;
      representatives of pharmaceutical companies, medical associations and the Children's&#xD;
      Endocrinology Association. Every eligible participant, wherever treated for his condition may&#xD;
      take part in the study.&#xD;
&#xD;
      The study design is to compare, in a controlled case-control manner, prospectively. The&#xD;
      development of ADHD characteristics in a group of patients from initiation to 12 months of&#xD;
      treatment with rhGH compared to a similar gender and age controlled group, not treated by&#xD;
      rhGH.&#xD;
&#xD;
      Statistical Analysis All data will be presented in mean ,min and max. The data will be&#xD;
      divided according to age and results.&#xD;
&#xD;
      Statistical analysis will be performed by ANOVA with repeated measures, which will examine&#xD;
      the difference between the trial and control group, at the 4 different time points, as well&#xD;
      as the difference in each patient for itself, the influence of time and the interaction&#xD;
      between these measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>ADHD criteria</measure>
    <time_frame>12 months</time_frame>
    <description>questionnaires analysis will give a definite number. Criteria will be compared between groups</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Growth Hormone Deficiency</condition>
  <condition>Attention Deficit Disorder</condition>
  <condition>Idiopathic Short Stature</condition>
  <arm_group>
    <arm_group_label>GH treated patients</arm_group_label>
    <description>All participants family member and teacher will fill questionnaires regarding signs of ateention deficit prior to GH treatment and after 6 and 12 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control</arm_group_label>
    <description>All participants family member and teacher will fill questionnaires regarding signs of atention deficit at baseline and after 6 and 12 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>All participants families will fulfill a periodic questionnaire regarding attention, behaviour.</description>
    <arm_group_label>GH treated patients</arm_group_label>
    <arm_group_label>Healthy control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        children ages 6-16 years receiving recombinant growth hormone will be compared to those&#xD;
        untereated&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children over the age of 6 years, and less than 16 years&#xD;
&#xD;
          -  Children eligible for rhGH treatment according to the following Food and Drug&#xD;
             Administration approved indications; Small for gesational age, Idioapathic short&#xD;
             stature, GH deficiency and chronic renal failure.&#xD;
&#xD;
          -  Consent of parents / guardian to participate in research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Under the age of 6 years and above 16 years&#xD;
&#xD;
          -  Previously diagnosed with neurocognitive disease&#xD;
&#xD;
          -  Previously diagnosed with specific syndromes: Prader-willi syndrome, Turner&#xD;
&#xD;
          -  Previously diagnosed with Attention Deficit/Hyperactivity disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>marianna Rachmiel, md</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assaf Haroffeh Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marianna Rachmiel, md</last_name>
    <phone>97289542007</phone>
    <email>mariannar@asaf.health.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assaf Haroffeh Medical center</name>
      <address>
        <city>Zrifin</city>
        <zip>70300</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marianna Rachmiel, md</last_name>
      <phone>972-8-9542007</phone>
      <email>mariannar@asaf.health.gov.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>August 7, 2022</last_update_submitted>
  <last_update_submitted_qc>August 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dwarfism</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02973061
org study id: 240/14
nct id: NCT02973061
lead sponsor: 
has dmc: No
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.
observational model: Case-Control
time perspective: Prospective
measure: ADHD criteria
time frame: 12 months
description: questionnaires analysis will give a definite number. Criteria will be compared between groups
arm group label: GH treated patients
description: All participants family member and teacher will fill questionnaires regarding signs of ateention deficit prior to GH treatment and after 6 and 12 months
arm group label: Healthy control
description: All participants family member and teacher will fill questionnaires regarding signs of atention deficit at baseline and after 6 and 12 months
intervention type: Other
intervention name: Questionnaires
description: All participants families will fulfill a periodic questionnaire regarding attention, behaviour.
arm group label: GH treated patients
arm group label: Healthy control
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
last name: marianna Rachmiel, md
role: Principal Investigator
affiliation: Assaf Haroffeh Medical Center
last name: Marianna Rachmiel, md
phone: 97289542007
email: mariannar@asaf.health.gov.il
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Dwarfism
mesh term: Attention Deficit Disorder with Hyperactivity
sharing ipd: No