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Trial record 15 of 43 for:    Recruiting, Not yet recruiting, Available Studies | "Dwarfism"

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

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ClinicalTrials.gov Identifier: NCT02973061
Recruitment Status : Recruiting
First Posted : November 25, 2016
Last Update Posted : November 25, 2016
Sponsor:
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center

Brief 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.


Condition or disease Intervention/treatment
Growth Hormone Deficiency Attention Deficit Disorder Idiopathic Short Stature Other: Questionnaires

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Impact of the Use of Recombinant Human Growth Hormone on Attention Hyperactivity Deficit Characteristics in Children and Adolescents
Study Start Date : January 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019


Group/Cohort Intervention/treatment
GH treated patients
All participants family member and teacher will fill questionnaires regarding signs of ateention deficit prior to GH treatment and after 6 and 12 months
Other: Questionnaires
All participants families will fulfill a periodic questionnaire regarding attention, behaviour.

Healthy control
All participants family member and teacher will fill questionnaires regarding signs of atention deficit at baseline and after 6 and 12 months
Other: Questionnaires
All participants families will fulfill a periodic questionnaire regarding attention, behaviour.




Primary Outcome Measures :
  1. ADHD criteria [ Time Frame: 12 months ]
    questionnaires analysis will give a definite number. Criteria will be compared between groups



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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
children ages 6-16 years receiving recombinant growth hormone will be compared to those untereated
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973061


Contacts
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Contact: Marianna Rachmiel, md 97289542007 mariannar@asaf.health.gov.il

Locations
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Israel
Assaf Haroffeh Medical center Recruiting
Zrifin, Israel, 70300
Contact: Marianna Rachmiel, md    972-8-9542007    mariannar@asaf.health.gov.il   
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
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Principal Investigator: marianna Rachmiel, md Assaf Haroffeh Medical Center

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Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT02973061     History of Changes
Other Study ID Numbers: 240/14
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Dwarfism, Pituitary
Dwarfism
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Genetic Diseases, Inborn
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs