Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age

Study Overview
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Brief Summary
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To estimate the percentage of children with serum IGF-1 > 2 standard deviation (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment.

Official Title
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Evolution of IGF-1 in Children Born Small for Gestational Age and With Growth Retardation, Treated by Genotonorm Especially Evolution After Dose Adaptation.

Conditions
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Fetal Growth Retardation

Intervention / Treatment
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* Drug: Genotonorm (Somatropin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronological age between 4 and 9 years for a boy and 4 and 7 years for a girl. Measured Height < -2.5 Standard Deviation Exclusion Criteria: Pubertal signs ie: testis volume > or = 4 ml in boys and breast stage > or = B2 (Tanner) Serious chronic disease (diabetes, renal insufficiency, heart failure, hepatic insufficiency, neoplasia)

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genotonorm (Somatropin)<br> | Drug: Genotonorm (Somatropin)<br>* 0.40 mg/kg/week dived in 7 daily subcutaneous injections during 2 years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Children With Insulin Growth Factor-1 (IGF-1) > 2 Standard Deviation (SD) at 9 and 12 Months | Percentage of children with serum IGF-1 > 2 SD (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment. 9 months and 12 months are combined. | 9 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Height SD Chronological Age (CA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | The height in SD was calculated using Sempe reference means and standard deviations for height. Change in height SD was calculated as height in SD at 12 months minus height in SD at Baseline. | Baseline, 12 months | 
| Change in Height SD CA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at 24 months minus height in SD at Baseline. | Baseline, 24 months | 
| Change in Height SD CA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months | The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at 12 or 24 months minus height in SD at Baseline. | Baseline, 12 and 24 months | 
| Change in Height SD Bone Age (BA) From Baseline at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at 12 months minus height in SD at Baseline. | Baseline, 12 months | 
| Change in Height SD BA From Baseline at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at 24 months minus height in SD at Baseline. | Baseline, 24 months | 
| Change in Height SD BA From Baseline at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months | The height in SD was calculated using Sempe reference means and SDs for height. Change in height SD was calculated as height in SD at 12 or 24 months minus height in SD at Baseline. | Baseline, 12 and 24 months | 
| Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | Growth rate SD CA at 12 months was calculated as:(Growth rate at 12 months minus reference mean for CA at 12 months) divided by reference SD for CA at 12 months Growth rate SD CA at 24 months was calculated as:(Growth rate at 24 months minus reference mean for CA at 24 months) divided by reference SD for CA at 24 months | 12 and 24 months | 
| Summary of Growth Rate SD (CA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months | Growth rate SD CA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for CA at 12 months) divided by reference SD for CA at 12 months Growth rate SD CA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for CA at 24 months) divided by reference SD for CA at 24 months | 12 and 24 months | 
| Summary of Growth Rate SD (BA) at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | Growth rate SD BA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for BA at 12 months) divided by reference SD for BA at 12 months | Baseline, 12 months | 
| Summary of Growth Rate SD (BA) at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | Growth rate SD BA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for BA at 24 months) divided by reference SD for BA at 24 months | Baseline, 24 months | 
| Summary of Growth Rate SD (BA) at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months | Growth rate SD BA at 12 months was calculated as: (Growth rate at 12 months minus reference mean for BA at 12 months) divided by reference SD for CA at 12 months Growth rate SD BA at 24 months was calculated as: (Growth rate at 24 months minus reference mean for BA at 24 months) divided by reference SD for CA at 24 months | 12 and 24 months | 
| Analysis of Covariance (ANCOVA) for Height SD CA at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months | Change in Height SD (CA) was calculated as: Height SD (CA) at 12 months minus Height SD (CA) at Baseline | Baseline, 12 months | 
| ANCOVA for Height SD CA at 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months | Height SD (CA) at 24 months. | Baseline, 24 months | 
| ANCOVA for Height SD BA at 12 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months | Change in Height SD (BA) was calculated as: Height SD (BA) at 12 months minus Height SD (BA) at Baseline | Baseline, 12 months | 
| ANCOVA for Height SD BA at 24 Months in Children With IGF-1 <= 2 SD at 9 or 12 Months and IGF-1 > 2 SD at 9 and 12 Months | Height SD (BA) at 24 months | Baseline, 24 months | 
| Summary of IGF-1 SD at 6, 9, 12, 15, 18, 21, and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months | IGF-1 SD was calculated at each study time point using gender specific IGF-1 reference mean and SD for the CA of the child on the date of the corresponding IGF-1 blood sample: IGF-1 SD = (IGF-1 minus reference mean) divided by reference SD | 6, 9, 12, 15, 18, 21, and 24 months | 
| Summary of IGF-1 SD at 6, 9, 12, 15, 18, 21, and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months | IGF-1 SD was calculated at each study time point using these gender specific IGF-1 reference means and SDs for the CA of the child on the date of the corresponding IGF-1 blood sample: IGF-1 SD = (IGF-1 - reference mean) / reference SD | 6, 9, 12, 15, 18, 21, and 24 months | 
| IGF-1/Insulin-Like Growth Factor Binding Protein 3 (IGFBP-3) Ratio at 12 and 24 Months in Children With IGF-1 < = 2 SD at 9 or 12 Months |  | 12 and 24 months | 
| IGF-1/IGFBP-3 Ratio at 12 and 24 Months in Children With IGF-1 > 2 SD at 9 and 12 Months |  | 12 and 24 months |