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

NCT02507245 | Completed

• 1 other identifier: Verbale N°4/2013
• Study Type: observational
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Growth Hormone Deficiency

Keywords

GHD

Outcome Measures

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

  1 year

Study Arms (1)

GHD Children

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

Drug: Growth Hormone-Releasing Hormone

Interventions

Growth Hormone-Releasing Hormone DRUG

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

GHD Children

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• GH deficiency

You may not qualify if:

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

Sponsors & Collaborators

• Stefania La Grutta, MD: lead

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Growth Hormone-Releasing Hormone

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

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: 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.

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: July 23, 2015
• Study Start: January 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 23, 2015

Record last verified: 2015-07