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

NCT ID: NCT02507245

Last Updated: 2015-07-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-05-31

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.

Conditions

Growth Hormone Deficiency

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

GHD Children

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

Growth Hormone-Releasing Hormone

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

GH

Eligibility 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stefania La Grutta, MD

OTHER

Sponsor Role: lead

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.

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

Verbale N°4/2013

Identifier Type: -

Identifier Source: org_study_id