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

NCT02973061 | Unknown

• 1 other identifier: 240/14
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Growth Hormone Deficiency; Attention Deficit Disorder; Idiopathic Short Stature

Outcome Measures

Primary Outcomes (1)

• ADHD criteria

  questionnaires analysis will give a definite number. Criteria will be compared between groups

  12 months

Study Arms (2)

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

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

Interventions

Questionnaires OTHER

All participants families will fulfill a periodic questionnaire regarding attention, behaviour.

GH treated patients; Healthy control

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children ages 6-16 years receiving recombinant growth hormone will be compared to those untereated

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf Haroffeh Medical center

Zrifin, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Dwarfism, Pituitary; Attention Deficit Disorder with Hyperactivity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Dwarfism; 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; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• marianna Rachmiel, md

  Assaf Haroffeh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianna Rachmiel, md

CONTACT

97289542007; mariannar@asaf.health.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 25, 2016
• Study Start: January 1, 2015
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)