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

Completed

• Conditions: Growth Hormone Deficiency
• Interventions: Drug: Growth Hormone-Releasing Hormone

• Registration Number: NCT02507245
• Lead Sponsor: Stefania La Grutta, MD

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.

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 Timeline

• Study Start: 2014-01
• Primary Completion: 2015-04
• Study Completion: 2015-05
• Study First Submitted: 2015-06-03
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-22
• Last Update Submitted: 2015-07-22
• Study First Posted: 2015-07-23
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Assessment of the developmental patterns of lung function before and after GH by spirometry	1 year	Assessment of lung function before and after administration of GH in children with growth hormone deficiency by spirometry