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

Growth Hormone Deficiency Clinical Trial

— GHD  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02507245
• Other study ID #: Verbale N°4/2013
• Status: Completed
• Phase: N/A
• First received: June 3, 2015
• Last updated: July 22, 2015
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Observational

Clinical 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 months of GH therapy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 15 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stefania La Grutta, MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No