Growth Hormone DeficiencyGHDNCT02507245
Observational Longitudinal Study in Children Affected by Idiopathic Growth Hormone Deficiency (GHD)
An observational study of Growth Hormone Deficiency, run by Stefania La Grutta, MD.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- Growth Hormone-Releasing Hormone
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- GH deficiency
Who cannot join
- Respiratory infections 4 weeks before the recruitment
- Children with autoimmune diseases
- Therapy with drugs able to modify the lung function
About this study
Official title: 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.
Read the 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.
- Conditions
- Growth Hormone Deficiency
- Being tested
- Growth Hormone-Releasing Hormone
- Keywords
- GHD
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth Hormone-Releasing HormoneDrug
Also called GH
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.
| Study group | Role | What they receive |
|---|---|---|
| GHD Children | Treatment with Growth Hormone-Releasing Hormone in children affected by idiopathic growth hormone deficiency (GHD) Receives: Drug: Growth Hormone-Releasing Hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the developmental patterns of lung function before and after GH by spirometry
Assessment of lung function before and after administration of GH in children with growth hormone deficiency by spirometry
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startJan 2014
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefania La Grutta, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507245
- Sponsor's protocol ID
- Verbale N°4/2013
- Acronym
- GHD
- Status last verified
- Jul 2015
- First submitted
- 3 Jun 2015
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02507245
- Acronym / sponsor ID
- GHD / Verbale N°4/2013
- Conditions
- Growth Hormone Deficiency
- Keywords
- GHD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Stefania La Grutta, MDUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GHD Children | – | Drug: Growth Hormone-Releasing HormoneTreatment with Growth Hormone-Releasing Hormone in children affected by idiopathic growth hormone deficiency (GHD) |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- GH deficiency
Key exclusion criteria (3 listed)
- Respiratory infections 4 weeks before the recruitment
- Children with autoimmune diseases
- Therapy with drugs able to modify the lung function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth Hormone-Releasing HormoneAlso: GHFrom 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. | Drug | GHD Children |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Deficiency, run by Stefania La Grutta, MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the developmental patterns of lung function before and after GH by spirometry (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2015.