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CompletedNCT02507245GHDUpdated Jul 23, 2015

Observational Longitudinal Study in Children Affected by Idiopathic Growth Hormone Deficiency (GHD)

An observational study in Growth Hormone Deficiency, sponsored by Stefania La Grutta, MD. Completed. Open to participants aged 5 Years to 15 Years. Per ClinicalTrials.gov, last updated 2015-07-23.

Sponsored by Stefania La Grutta, MD · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
48
Ages
5 Years to 15 Years
Sex
All
01

Study 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 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.

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Conditions studied

  • Growth Hormone Deficiency

Keywords

  • GHD
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In context

Dwarfism, Pituitary

164 studies on the registry are indexed under Dwarfism, Pituitary; 25 are open to participants now.

This study's enrollment of 48 is below the median of 200 across 37 observational studies indexed under Dwarfism, Pituitary.

Browse Dwarfism, Pituitary studies →

Lead sponsor

Stefania La Grutta, MD is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • GH deficiency

Exclusion criteria

Exclusion Criteria:

  • Respiratory infections 4 weeks before the recruitment
  • Children with autoimmune diseases
  • Therapy with drugs able to modify the lung function
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
48 participants (actual)
Patient registry
No

Groups and cohorts

  • GHD Children

    Treatment with Growth Hormone-Releasing Hormone in children affected by idiopathic growth hormone deficiency (GHD)

    Drug: Growth Hormone-Releasing Hormone

Interventions

  • DrugGrowth Hormone-Releasing Hormone

    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.

    Also known as: GH

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02507245
Lead sponsor
Stefania La Grutta, MD
Responsible party
Stefania La Grutta, MD (Stefania La Grutta, MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy., Istituto per la Ricerca e l'Innovazione Biomedica) — Sponsor-investigator
First posted
Jul 23, 2015
Start date
Jan 2014
Primary completion
Apr 2015
Completion
May 2015
Last update
Jul 23, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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