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

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ClinicalTrials.gov Identifier: NCT02507245
Recruitment Status : Completed
First Posted : July 23, 2015
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):
Stefania La Grutta, MD, Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy

Brief 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.

Condition or disease Intervention/treatment
Growth Hormone Deficiency Drug: Growth Hormone-Releasing Hormone

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
Actual Enrollment : 48 participants
Observational Model: Case-Only
Time Perspective: Prospective
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)
Study Start Date : January 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015


Group/Cohort Intervention/treatment
GHD Children
Treatment with Growth Hormone-Releasing Hormone in children affected by idiopathic growth hormone deficiency (GHD)
Drug: Growth 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.
Other Name: GH




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   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.
Criteria

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

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 di Biomedicina e Immunologia Molecolare Alberto Monroy
ClinicalTrials.gov Identifier: NCT02507245     History of Changes
Other Study ID Numbers: Verbale N°4/2013
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: July 2015

Keywords provided by Stefania La Grutta, MD, Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy:
GHD

Additional relevant MeSH terms:
Growth Hormone-Releasing Hormone
Endocrine System Diseases
Dwarfism, Pituitary
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
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs