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NCT Number: NCT02507245

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

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Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: GH

Primary outcomes

  1. Assessment of the developmental patterns of lung function before and after GH by spirometry

    Time frame: 1 year

    Assessment of lung function before and after administration of GH in children with growth hormone deficiency by spirometry

Sponsors and collaborators

Lead sponsor

Stefania La Grutta, MD

Other

Registry information

Official study 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)

Acronym: GHD

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 23, 2015
Registry last updated
Jul 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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