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

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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02507245
Acronym
GHD
Enrollment
48
Registered
2015-07-23
Start date
2014-01-31
Completion date
2015-05-31
Last updated
2015-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Deficiency

Keywords

GHD

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.

Interventions

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.

Sponsors

Stefania La Grutta, MD
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of the developmental patterns of lung function before and after GH by spirometry1 yearAssessment of lung function before and after administration of GH in children with growth hormone deficiency by spirometry

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026