An observational study in Short Stature and Short; Stature, Psychosocial, sponsored by Istituto Auxologico Italiano. Completed at 1 site in Italy. Open to participants aged 6 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by Istituto Auxologico Italiano · Observational
The first aim of the present study is to evaluate the psychological impact of the condition of short stature (family) in a sample of Italian children, comparing them with subjects of normal stature, measuring their levels of psychological well-being, psychological distress, quality of health-related life and any behavioral issues. The secondary objective is to study the psychological impact evaluated with the tests described below (see methods section) in children with GH deficiency and the effects of replacement therapy (6 months) with GH from recombinant DNA.
The observational study carried out at the Centre for growth and pubertal Disorders, Istituto Auxologico Italiano, IRCCS, Milan, consists of two sub-projects that involve the recruitment of:
Children with GH deficiency will be evaluated in baseline conditions and after 6 months of therapy with recombinant DNA GH (at a dose of 0.025-0.035 mg/kg of body weight per day (or 0.7-1.0 mg/m2 of body surface area per day).
The following variables will be investigated in the recruited subjects of the two subgroups:
99 studies on the registry are indexed under Dwarfism; 12 are open to participants now.
This study's enrollment of 80 is above the median of 60 across 30 observational studies indexed under Dwarfism.
Browse Dwarfism studies →Istituto Auxologico Italiano is the lead sponsor of 202 studies on the registry; 68 are open to participants now.
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35 children with familiar short stature, 35 with normal height (height > 25th centile), and 10 with growth hormone deficiency and their caregivers of reference (see above the description of the diagnostic criteria).
Inclusion Criteria: age between 6 and 14 years, of both sexes
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
- 35 children, aged between 6 and 14 years, of both sexes, with familial short stature (height \< 3rd centile according to the Italian reference standards) and their caregivers of reference. Children with familial short stature will be characterized by: short stature in other members of the family group, not necessarily the parents, harmonious appearance, without particular clinical signs and normal pubertal development, parallel growth curve below the 3rd centile, bone age corresponding to chronological age. Children and teenagers with obesity (BMI \> 97th centile) will be excluded
35 children, aged between 6 and 14 years, of both sexes, with normal height (height \> 25th centile) and weight.
10 children, aged between 6 and 14 years, of both sexes, affected by isolated GH deficiency according to the criteria established by AIFA note 39 for this pathology (short stature: ≤ -3 SD or ≤ -2 SD and growth velocity/year ≤ -1.0 SD for age and sex evaluated at least 6 months apart and peak GH at two different pharmacological stimulus tests \< 8 ng/ml). The exclusion criterion from the present study (and from treatment with rhGH) will be the presence of organic pathologies at the hypothalamic-pituitary level (assessed by performing brain MRI). Children with GH deficiency are evaluated in baseline conditions and after 6 months of therapy with recombinant DNA GH (at a dose of 0.025-0.035 mg/kg of body weight per day (or 0.7-1.0 mg/m2 of body surface area per day).
Drug: Recombinant human growth hormone (only for children with growth hormone deficiency)
Drug page: Human Growth Hormone
6 months of therapy with recombinant DNA GH (at a dose of 0.025-0.035 mg/kg of body weight per day (or 0.7-1.0 mg/m2 of body surface area per day).
Psychological well-being through the Psychological Well-Being Scales (PWB)
A self-administered questionnaire consisting of 18 items that investigates the degree of psychological well-being by exploring six dimensions: self-acceptance, positive relationships with others, autonomy, environmental control, personal growth, and purpose of life. The questionnaire consists of 18 items on a 4-step Likert scale.
Time frame: Baseline for the three groups; baseline and after 6 months for children with growth hormone deficiency
Psychological distress through the Depression Anxiety Stress Scale (DASS-21)
A 21-item self-report tool that measures various negative internal states: depression, anxiety, and stress.
Time frame: Baseline for the three groups; baseline and after 6 months for children with growth hormone deficiency
Quality of life through the Quality of Life in Short Stature Youth (QoLISSY),
A 50-item domain-specific questionnaire that measures health-related quality of life in children with short stature.
Time frame: Baseline for the three groups; baseline and after 6 months for children with growth hormone deficiency
Skills and problems through the Strengths and Difficulties Questionnaire (SDQ)
A questionnaire made up of 25 items able to assess emotional symptoms, behavioral problems, hyperactivity/inattention, problematic relationships with peers, and prosocial behavior.
Time frame: Baseline for the three groups; baseline and after 6 months for children with growth hormone deficiency
Behavioral problems through the Child Behaviour Checklist for Children (CBCL)
A questionnaire to be administered to parents or caregivers of children to detect any behavioral problems in their children. The instrument consists of 113 items that investigate three general scales: total problems, internalizing problems, and externalizing problems and 8 syndromic scales: social withdrawal, somatic complaints, anxiety, depression, social problems, thinking problems, attention problems, antisocial behavior, and aggressive behavior).
Time frame: Baseline for the three groups; baseline and after 6 months for the parents of children with growth hormone deficiency
Ran from May 2023 to primary completion in Jan 2024, 8 months.
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