- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02507245
Observational Longitudinal Study in Children Affected by Idiopathic Growth Hormone Deficiency (GHD) (GHD)
July 22, 2015 updated by: Stefania La Grutta, MD
Observational Longitudinal Study in Children Affected by Idiopathic Growth Hormone Deficiency (GHD): Lung Function Parameters Assessment; Quality of Life Assessment; Stress Parenting Assessment (Pneumo GHD)
The aim of this study is to assess the developmental patterns of lung function in children affected by growth hormone deficiency after one year of GH therapy.The assessment by specific questionnaires of quality of life and of parental stress index.Parameters will be evaluated at the time of the diagnosis and after 12 months of GH therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Observational longitudinal study in children affected by idiopathic growth hormone deficiency (GHD): lung function parameters assessment; quality of life assessment; stress parenting assessment (Pneumo GHD).
The aim of this study is to assess the developmental patterns of lung function in children affected by growth hormone deficiency after one year of GH therapy.The assessment by specific questionnaires of quality of life and of parental stress index.Parameters will be evaluated at the time of the diagnosis and after 12 months of GH therapy.
Study Type
Observational
Enrollment (Actual)
48
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
48 children affected by GH deficiency , recruited in the outpatient clinic of Pediatric Allergology & Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.
Description
Inclusion Criteria:
- GH deficiency
Exclusion Criteria:
- Respiratory infections 4 weeks before the recruitment
- Children with autoimmune diseases
- Therapy with drugs able to modify the lung function
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
GHD Children
Treatment with Growth Hormone-Releasing Hormone in children affected by idiopathic growth hormone deficiency (GHD)
|
From Baseline Visit (T0) to 6th Month Visit 0,025 mg/kg Growth Hormone/die.
From 6th Month Visit to 12th Month Visit 0,030 mg/Kg Growth Hormone/die.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of the developmental patterns of lung function before and after GH by spirometry
Time Frame: 1 year
|
Assessment of lung function before and after administration of GH in children with growth hormone deficiency by spirometry
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
June 3, 2015
First Submitted That Met QC Criteria
July 22, 2015
First Posted (Estimate)
July 23, 2015
Study Record Updates
Last Update Posted (Estimate)
July 23, 2015
Last Update Submitted That Met QC Criteria
July 22, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Musculoskeletal Diseases
- Hypothalamic Diseases
- Bone Diseases
- Bone Diseases, Endocrine
- Pituitary Diseases
- Dwarfism
- Bone Diseases, Developmental
- Hypopituitarism
- Dwarfism, Pituitary
- Endocrine System Diseases
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormones
- Growth Hormone-Releasing Hormone
Other Study ID Numbers
- Verbale N°4/2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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